Primary Immunodeficiency Syndrome Clinical Trial
— NGAM-05Official 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)
Verified date | October 2012 |
Source | Octapharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Completion of the main study NGAM 01, - At each of the last three 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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Immunoe Research Center | Centennial | Colorado |
United States | Rush Universtity Medical Center | Chicago | Illinois |
United States | University of California Irvine | Irvine | California |
United States | Midlands Pediatrics | Papillion | Nebraska |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Cardinal Glennon Children's Hospital | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Octapharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Efficacy: IgG trough levels are to be recorded, as they are required for dosing. Safety: 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. |
18 months | No |