High Infusion Speed Study (NGAM-05)
This is a prospective, open-label, non-controlled, non-randomised multicentre Phase III study of two multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study) for three months.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- To assess the safety and tolerability of NewGam when administered at infusion rates from 0.08 mL/kg/min (the maximum rate in study NGAM-01) to 0.14 mL/kg/min. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Efficacy: IgG trough levels are to be recorded, as they are required for dosing.
- Occurrence of AEs.
- Proportion of infusions with 1 or more temporally associated AEs.
- Short term tolerance parameters including vital signs.
- Laboratory parameters. Quality of life.
|Study Start Date:||March 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|United States, California|
|University of California Irvine|
|Irvine, California, United States|
|United States, Colorado|
|Immunoe Research Center|
|Centennial, Colorado, United States|
|United States, Illinois|
|Rush Universtity Medical Center|
|Chicago, Illinois, United States|
|United States, Missouri|
|Cardinal Glennon Children's Hospital|
|St. Louis, Missouri, United States|
|United States, Nebraska|
|Papillion, Nebraska, United States|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States|