NCT00161993

Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.

Conditions

• Primary Immunodeficiency Diseases (PID)
• Agammaglobulinemia
• Hypogammaglobulinemia

Interventions

Type	Name	Description
DRUG	Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution
DRUG	Gammagard S/D (Solvent/Detergent)

Timeline

• Start date: 2002-06-13
• Primary completion: 2003-09-24
• Completion: 2003-09-24
• First posted: 2005-09-13
• Last updated: 2021-08-24

Locations

6 sites across 2 countries: Finland, Sweden