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:

  1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
  2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
  3. The half-life of Vigam® Liquid after 4 months of treatment.
  4. 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