Trial Outcomes & Findings for Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases (NCT NCT00811174)

NCT ID: NCT00811174

Last Updated: 2017-07-14

Results Overview

Occurrence of Adverse Events

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

During infusion or within 72 hours after end of infusion

Results posted on

2017-07-14

Participant Flow

Patients previously treated with commercial Octagam 5% were to be enrolled in the study on the basis of the in- and exclusion criteria defined in the study protocol. Patients were to be enrolled only after written informed consent by the patient had been obtained.

Participant milestones

Participant milestones
Measure	Octagam 10% Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Octagam 10% Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Overall Study Protocol Violation	2
Overall Study Sponsors Decision	1

Baseline Characteristics

Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Octagam 10% n=5 Participants Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Age, Categorical <=18 years	2 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants

PRIMARY outcome

Timeframe: During infusion or within 72 hours after end of infusion

Occurrence of Adverse Events

Outcome measures

Outcome measures
Measure	Octagam 10% n=5 Participants Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Adverse Events	4 participants

PRIMARY outcome

Timeframe: after 6 months of treatment

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during each treatment

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at each treatment date (every three to four weeks)

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every three months

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before each treatment

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before treatement 10 and 13 (of 13 or 17 treatments) and at the end

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Due to premature termination of the study, data were unavailable and no analysis was done.

Outcome measures

Outcome data not reported

Adverse Events

Octagam 10%

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Octagam 10% n=5 participants at risk Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Skin and subcutaneous tissue disorders surgery for inguinal condyloma	20.0% 1/5 • Number of events 1 • 12 Months In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.

Other adverse events

Other adverse events
Measure	Octagam 10% n=5 participants at risk Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Respiratory, thoracic and mediastinal disorders nasopharyngitis	60.0% 3/5 • Number of events 3 • 12 Months In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.
Respiratory, thoracic and mediastinal disorders upper respirotory infection	60.0% 3/5 • Number of events 3 • 12 Months In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.
Gastrointestinal disorders gastroenteritis	40.0% 2/5 • Number of events 2 • 12 Months In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.
Respiratory, thoracic and mediastinal disorders cough	40.0% 2/5 • Number of events 2 • 12 Months In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.
Respiratory, thoracic and mediastinal disorders pharyngolarynngolaryngeal pain	40.0% 2/5 • Number of events 2 • 12 Months In summary, the assessment of adverse events, laboratory variables and other safety-related observations revealed no reasons for concern about the safety of Octagam 10%.

Additional Information

Michael Eppolito

Octapharma

Phone: 201-604-1155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place