Clinical Trial: A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.
Brief Summary:
To determine:
- The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
- The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
- The half-life of Vigam® Liquid after 4 months of treatment.
- The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.
Detailed Summary:
Sponsor: Bio Products Laboratory
Current Primary Outcome: IgG half-life [ Time Frame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bio Products Laboratory
Dates:
Date Received: September 2, 2014
Date Started: April 1999
Date Completion:
Last Updated: September 19, 2014
Last Verified: August 2014