Clinical Study to Evaluate the Safety and Tolerability of Immunoglobulin Intravenous (Human) 10% (NewGam) Administered at High Infusion Rates to Patients With Primary Immunodeficiency Diseases (Extension of Study NGAM-01)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Primary Immunodeficiency Disease
- Sponsor
- Octapharma
- Enrollment
- 21
- Locations
- 6
- Primary Endpoint
- Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 [NGAM-01]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.
Detailed Description
Patients received NewGam via an infusion pump to control precise infusion rates. All NewGam infusions started at a rate of 0.01 mL/kg/min (60 mg/kg/h) for the first 30 minutes followed by 0.03 mL/kg/min (180 mg/kg/h) for the next 15 minutes. If tolerated, further increments were made at predefined patterns with the following maximum rates: 0.10 mL/kg/min (600 mg/kg/h) in the first infusion; if this was tolerated, 0.12 mL/kg/min (720 mg/kg/h) in the second infusion; if this was tolerated, 0.14 mL/kg/min (840 mg/kg/h) in all subsequent infusions. If an adverse event occurred during an infusion, the rate was reduced to half the rate at which the event occurred or the infusion was interrupted until symptoms subsided. The infusion was then resumed at a rate tolerated by the patient.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completion of the main study NGAM-
- •At each of the last 3 infusions in the main study NGAM-01, administration of NewGam at the maximum infusion rate of 0.08 mL/kg/min and without the need for premedication.
Exclusion Criteria
- •Any condition or circumstance that would have led to the exclusion of the subject from the NGAM-01 study.
- •Administration of any immunoglobulin infusion other than NewGam between conclusion of the NGAM-01 study and the beginning of the present study.
- •A deviation of the subject's treatment interval of more than 7 days between the last infusion of NewGam in the NGAM-01 study and the first infusion of NewGam in the present study.
Outcomes
Primary Outcomes
Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug
Time Frame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)
An adverse event was considered to be temporally related to the study drug if it started during an infusion or within 72 hours after the end of an infusion.
Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug
Time Frame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)
An adverse event was considered to be causally related to the administration of the study drug if it judged to be probably or possibly related to the study drug, as assessed by the investigator.
Secondary Outcomes
- Change From Baseline in the Quality of Life (QoL) at the End of the Study(Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months))