Trial Outcomes & Findings for Study of PlasmaCap IG in Adults and Children With PIDD (NCT NCT03238079)
NCT ID: NCT03238079
Last Updated: 2026-06-30
Results Overview
The primary efficacy endpoint was the rate of acute SBI (pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, visceral abscess) per participant during the 12-month study observation period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
1 year
Results posted on
2026-06-30
Participant Flow
A total of 63 patients were enrolled between September 2017 and August 2020 at 13 sites across the United States and Canada.
Participant milestones
| Measure |
Adults
Adult participants \> 17 years received PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
|
Pediatrics
Pediatric participants \< 17 years received PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
15
|
|
Overall Study
COMPLETED
|
42
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
\[Not Specified\]
Baseline characteristics by cohort
| Measure |
Adults
n=48 Participants
Adult participants \> 17 years received PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
|
Pediatrics
n=15 Participants
Pediatric participants \< 17 years received PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Continuous
|
49.4 Years
STANDARD_DEVIATION 14.3 • n=20 Participants • \[Not Specified\]
|
8.9 Years
STANDARD_DEVIATION 4.4 • n=20 Participants • \[Not Specified\]
|
39.8 Years
STANDARD_DEVIATION 21.5 • n=40 Participants • \[Not Specified\]
|
|
Sex: Female, Male
Female
|
27 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
60 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Body Mass Index
|
30.14 kg/m2
STANDARD_DEVIATION 7.72 • n=20 Participants
|
25.54 kg/m2
STANDARD_DEVIATION 25.41 • n=20 Participants
|
29.03 kg/m2
STANDARD_DEVIATION 14.04 • n=40 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participants receiving PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
The primary efficacy endpoint was the rate of acute SBI (pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, visceral abscess) per participant during the 12-month study observation period
Outcome measures
| Measure |
Pediatrics
n=15 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \< 17 years.
|
Adults
n=48 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \> 17 years.
|
|---|---|---|
|
Mean Acute Serious Bacterial Infection (SBI) Rate
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: Up to 1 year per participantPopulation: Participants receiving PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
The average serum total IgG trough concentration
Outcome measures
| Measure |
Pediatrics
n=15 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \< 17 years.
|
Adults
n=48 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \> 17 years.
|
|---|---|---|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 13
|
1061.3 mg/mL
Standard Deviation 241.1
|
1007.5 mg/mL
Standard Deviation 189.5
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 14
|
1198.9 mg/mL
Standard Deviation 183.9
|
1090.1 mg/mL
Standard Deviation 266.9
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 15
|
1154.9 mg/mL
Standard Deviation 223.4
|
1057.4 mg/mL
Standard Deviation 223.5
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 16
|
1117.3 mg/mL
Standard Deviation 205.5
|
1092.4 mg/mL
Standard Deviation 261.9
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 17
|
1171.6 mg/mL
Standard Deviation 230.1
|
1139.6 mg/mL
Standard Deviation 241.5
|
|
Immunoglobulin G (IgG) Trough Concentration
Safety Follow-Up
|
1110.1 mg/mL
Standard Deviation 322.0
|
1010.8 mg/mL
Standard Deviation 208.1
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 1 (Pre-dose)
|
925.5 mg/mL
Standard Deviation 239.4
|
974.3 mg/mL
Standard Deviation 175.6
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 2
|
951.0 mg/mL
Standard Deviation 213.6
|
977.8 mg/mL
Standard Deviation 177.0
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 3
|
996.0 mg/mL
Standard Deviation 212.0
|
975.8 mg/mL
Standard Deviation 204.9
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 4
|
1041.7 mg/mL
Standard Deviation 230.9
|
963.1 mg/mL
Standard Deviation 182.8
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 5
|
1027.9 mg/mL
Standard Deviation 217.3
|
976.2 mg/mL
Standard Deviation 194.8
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 6
|
1071.0 mg/mL
Standard Deviation 205.3
|
951.9 mg/mL
Standard Deviation 193.0
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 7
|
1011.3 mg/mL
Standard Deviation 209.4
|
980.0 mg/mL
Standard Deviation 185.1
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 8
|
1039.6 mg/mL
Standard Deviation 258.2
|
967.5 mg/mL
Standard Deviation 200.4
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 9
|
1077.7 mg/mL
Standard Deviation 236.3
|
970.4 mg/mL
Standard Deviation 200.7
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 10
|
1047.3 mg/mL
Standard Deviation 193.8
|
992.6 mg/mL
Standard Deviation 203.7
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 11
|
1075.8 mg/mL
Standard Deviation 230.4
|
999.2 mg/mL
Standard Deviation 197.3
|
|
Immunoglobulin G (IgG) Trough Concentration
Infusion 12
|
1054.1 mg/mL
Standard Deviation 201.3
|
1016.0 mg/mL
Standard Deviation 215.7
|
SECONDARY outcome
Timeframe: Up to 1 year per participantPopulation: Participants receiving PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
The number of days out of work/school/daycare or unable to perform normal daily activities due to infections
Outcome measures
| Measure |
Pediatrics
n=15 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \< 17 years.
|
Adults
n=48 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \> 17 years.
|
|---|---|---|
|
Days Unable to Perform Daily Activities
|
8.1 Days
Standard Deviation 11.6
|
6.0 Days
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Up to 1 year per participantPopulation: Participants receiving PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days)
Number of participants with maintenance of stable IgG levels
Outcome measures
| Measure |
Pediatrics
n=15 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \< 17 years.
|
Adults
n=48 Participants
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \> 17 years.
|
|---|---|---|
|
Therapeutic IgG Levels
|
15 Participants
|
48 Participants
|
Adverse Events
Adults
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
Pediatrics
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adults
n=48 participants at risk
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \> 17 years.
|
Pediatrics
n=15 participants at risk
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \< 17 years.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.1%
1/48 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Pyelonephritis
|
2.1%
1/48 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Viral infection
|
2.1%
1/48 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
2.1%
1/48 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
Other adverse events
| Measure |
Adults
n=48 participants at risk
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \> 17 years.
|
Pediatrics
n=15 participants at risk
PlasmaCap IG (10% Immunoglobulin Intravenous \[IGIV\]) administered by infusion at a dose between 300-900 mg/kg/infusion every 21 days (± 2 days) or 28 days (± 2 days) in participants \< 17 years.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
10.4%
5/48 • Number of events 6 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Acute sinusitis
|
8.3%
4/48 • Number of events 6 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
4.2%
2/48 • Number of events 2 • From enrollment to end of follow-up at 1 year
|
13.3%
2/15 • Number of events 7 • From enrollment to end of follow-up at 1 year
|
|
Injury, poisoning and procedural complications
Procedural headache
|
10.4%
5/48 • Number of events 12 • From enrollment to end of follow-up at 1 year
|
6.7%
1/15 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
5/48 • Number of events 6 • From enrollment to end of follow-up at 1 year
|
26.7%
4/15 • Number of events 10 • From enrollment to end of follow-up at 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
4/48 • Number of events 4 • From enrollment to end of follow-up at 1 year
|
6.7%
1/15 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
|
Nervous system disorders
Headache
|
39.6%
19/48 • Number of events 58 • From enrollment to end of follow-up at 1 year
|
60.0%
9/15 • Number of events 66 • From enrollment to end of follow-up at 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
7/48 • Number of events 7 • From enrollment to end of follow-up at 1 year
|
46.7%
7/15 • Number of events 10 • From enrollment to end of follow-up at 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
6/48 • Number of events 7 • From enrollment to end of follow-up at 1 year
|
26.7%
4/15 • Number of events 5 • From enrollment to end of follow-up at 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
2/48 • Number of events 2 • From enrollment to end of follow-up at 1 year
|
26.7%
4/15 • Number of events 8 • From enrollment to end of follow-up at 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
4/48 • Number of events 5 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
2/48 • Number of events 3 • From enrollment to end of follow-up at 1 year
|
20.0%
3/15 • Number of events 8 • From enrollment to end of follow-up at 1 year
|
|
Gastrointestinal disorders
Nausea
|
10.4%
5/48 • Number of events 7 • From enrollment to end of follow-up at 1 year
|
33.3%
5/15 • Number of events 5 • From enrollment to end of follow-up at 1 year
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
4/48 • Number of events 5 • From enrollment to end of follow-up at 1 year
|
40.0%
6/15 • Number of events 7 • From enrollment to end of follow-up at 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
6/48 • Number of events 12 • From enrollment to end of follow-up at 1 year
|
13.3%
2/15 • Number of events 2 • From enrollment to end of follow-up at 1 year
|
|
General disorders
Fatigue
|
20.8%
10/48 • Number of events 13 • From enrollment to end of follow-up at 1 year
|
26.7%
4/15 • Number of events 10 • From enrollment to end of follow-up at 1 year
|
|
General disorders
Pyrexia
|
14.6%
7/48 • Number of events 10 • From enrollment to end of follow-up at 1 year
|
33.3%
5/15 • Number of events 7 • From enrollment to end of follow-up at 1 year
|
|
General disorders
Pain
|
10.4%
5/48 • Number of events 6 • From enrollment to end of follow-up at 1 year
|
6.7%
1/15 • Number of events 1 • From enrollment to end of follow-up at 1 year
|
|
General disorders
Chills
|
8.3%
4/48 • Number of events 6 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
General disorders
Influenza like illness
|
8.3%
4/48 • Number of events 4 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
General disorders
Malaise
|
4.2%
2/48 • Number of events 2 • From enrollment to end of follow-up at 1 year
|
13.3%
2/15 • Number of events 4 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Sinusitis
|
25.0%
12/48 • Number of events 18 • From enrollment to end of follow-up at 1 year
|
6.7%
1/15 • Number of events 3 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
20.8%
10/48 • Number of events 15 • From enrollment to end of follow-up at 1 year
|
13.3%
2/15 • Number of events 3 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Nasopharyngitis
|
14.6%
7/48 • Number of events 11 • From enrollment to end of follow-up at 1 year
|
33.3%
5/15 • Number of events 9 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Influenza
|
8.3%
4/48 • Number of events 5 • From enrollment to end of follow-up at 1 year
|
20.0%
3/15 • Number of events 3 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.6%
7/48 • Number of events 9 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Viral infection
|
6.2%
3/48 • Number of events 3 • From enrollment to end of follow-up at 1 year
|
20.0%
3/15 • Number of events 4 • From enrollment to end of follow-up at 1 year
|
|
Infections and infestations
Bronchitis
|
10.4%
5/48 • Number of events 8 • From enrollment to end of follow-up at 1 year
|
0.00%
0/15 • From enrollment to end of follow-up at 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place