Trial Outcomes & Findings for Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency (NCT NCT01465958)
NCT ID: NCT01465958
Last Updated: 2015-03-13
Results Overview
Steady-state area under the curve (AUC): For the IV phase, the mean adjusted AUC was calculated for all 11 subjects, which included subjects on both 3 and 4 week intravenous (IV) dosing schedules and who had sufficient immunoglobulin G (IgG) data. For the SC phase, the mean AUC was calculated for 10 subjects on weekly subcutaneous (SC) administration and who had sufficient IgG data.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
4 to 5 weeks for IV administration; 12 weeks for SC administration
Results posted on
2015-03-13
Participant Flow
A total of 13 subjects were screened for participation in this study. After screening, one subject discontinued the study and did not receive study drug. Eleven subjects entered the Run-in phase. One subject entered intravenous Gamunex-C phase directly. A total of 11 subjects entered the IV phase and subsequently entered the SC phase.
Participant milestones
| Measure |
Intravenous GAMUNEX-C
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
|
Subcutaneous GAMUNEX-C
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|---|
|
Run-in Phase
STARTED
|
11
|
0
|
|
Run-in Phase
COMPLETED
|
10
|
0
|
|
Run-in Phase
NOT COMPLETED
|
1
|
0
|
|
Intravenous (IV) Phase
STARTED
|
11
|
0
|
|
Intravenous (IV) Phase
COMPLETED
|
11
|
0
|
|
Intravenous (IV) Phase
NOT COMPLETED
|
0
|
0
|
|
Subcutaneous (SC) Phase
STARTED
|
0
|
11
|
|
Subcutaneous (SC) Phase
COMPLETED
|
0
|
10
|
|
Subcutaneous (SC) Phase
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Intravenous GAMUNEX-C
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
|
Subcutaneous GAMUNEX-C
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|---|
|
Run-in Phase
Protocol Violation
|
1
|
0
|
|
Subcutaneous (SC) Phase
Adverse Event
|
0
|
1
|
Baseline Characteristics
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency
Baseline characteristics by cohort
| Measure |
Safety Population
n=12 Participants
The safety population consisted of all subjects who received any amount of GAMUNEX-C. In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. In the SC Phase, subjects received weekly subcutaneous infusion of Gamunex-C at a mg/kg dose based on intravenous dose of the subject and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 3.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 4 to 5 weeks for IV administration; 12 weeks for SC administrationPopulation: The PK population included the subjects with the availability of sufficient pharmacokinetics (PK) data to calculate area under the curve (AUC) for either the IV or SC phases.
Steady-state area under the curve (AUC): For the IV phase, the mean adjusted AUC was calculated for all 11 subjects, which included subjects on both 3 and 4 week intravenous (IV) dosing schedules and who had sufficient immunoglobulin G (IgG) data. For the SC phase, the mean AUC was calculated for 10 subjects on weekly subcutaneous (SC) administration and who had sufficient IgG data.
Outcome measures
| Measure |
Intravenous GAMUNEX-C
n=11 Participants
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
|
Subcutaneous GAMUNEX-C
n=10 Participants
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|---|
|
Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG)
|
216873.7 h*mg/dL
Interval 162277.0 to 291785.0
|
230830.0 h*mg/dL
Interval 187577.0 to 303913.0
|
PRIMARY outcome
Timeframe: 4 - 5 weeks of IV administration and 12 weeks for SC administrationPopulation: The IgG Population was used to calculate the trough serum concentrations. The IgG population consisted of all subjects who received any amount of GAMUNEX-C and had any serum total IgG concentration data.
Mean trough serum total IgG values were calculated for each subject for the IV Phase (IV #1 and IV #2) and the SC phase (SC Weeks #9 and #12, and End of Treatment/Early termination visit). Mean trough concentration values of serum total IgG during the IV and SC phases were calculated based on the IgG population (subjects who received any amount of study drug and had serum total IgG concentration data).
Outcome measures
| Measure |
Intravenous GAMUNEX-C
n=11 Participants
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
|
Subcutaneous GAMUNEX-C
n=10 Participants
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|---|
|
Mean Trough of Serum Total IgG
|
997.2 mg/dL
Interval 784.0 to 1320.0
|
1325.0 mg/dL
Interval 1077.0 to 1690.0
|
Adverse Events
Intravenous GAMUNEX-C
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Subcutaneous GAMUNEX-C
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravenous GAMUNEX-C
n=12 participants at risk
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
|
Subcutaneous GAMUNEX-C
n=11 participants at risk
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
Other adverse events
| Measure |
Intravenous GAMUNEX-C
n=12 participants at risk
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
|
Subcutaneous GAMUNEX-C
n=11 participants at risk
GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
|
|---|---|---|
|
General disorders
Infusion site erythema
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
63.6%
7/11 • Number of events 11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
infusion site pain
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
54.5%
6/11 • Number of events 9 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site pruritus
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
54.5%
6/11 • Number of events 19 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site discomfort
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
27.3%
3/11 • Number of events 12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site haematoma
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
27.3%
3/11 • Number of events 10 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
18.2%
2/11 • Number of events 2 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site swelling
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
18.2%
2/11 • Number of events 4 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Nervous system disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
18.2%
2/11 • Number of events 2 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
18.2%
2/11 • Number of events 2 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Immune system disorders
Drug hypersensitivity
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Gastroenteritis viral
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site induration
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 2 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site inflammation
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Infusion site warmth
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Rhinovirus infection
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
9.1%
1/11 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Croup infectious
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Renal and urinary disorders
Incontinence
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Injury, poisoning and procedural complications
Joint sprain
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Social circumstances
Learning disability
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Molluscum contagiosum
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
|
Infections and infestations
Viral pharyngitis
|
8.3%
1/12 • Number of events 1 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
0.00%
0/11 • Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60