High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
Completed · Phase 3
Conditions studied: Primary Immunodeficiency Disease
In brief
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.
Key facts
- Study ID
- NCT01313507
- Run by
- Octapharma
- People needed
- 21
- Starts
- 2011-05-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California Irvine — Irvine, California, United States
- Immunoe Research Center — Centennial, Colorado, United States
- Rush Universtity Medical Center — Chicago, Illinois, United States
- Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
- Midlands Pediatrics — Papillion, Nebraska, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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