Phase 3
Completed N=21
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
Primary Immunodeficiency Disease
Source: ClinicalTrials.gov NCT01313507 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug — 19.0 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug |
19.0 | — |
| PRIMARY Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug |
38.1 | — |
| SECONDARY Change From Baseline in the Quality of Life (QoL) at the End of the Study |
-2.63; -2.01; 0.21; 0.36 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of the main study NGAM-01.
- 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.
Data sourced from ClinicalTrials.gov (NCT01313507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.