Trials / Completed
CompletedNCT00157079
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immune Globulin Intravenous (Human), 10% |
Timeline
- Start date
- 2002-06-25
- Primary completion
- 2003-12-16
- Completion
- 2003-12-16
- First posted
- 2005-09-12
- Last updated
- 2021-08-24
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00157079. Inclusion in this directory is not an endorsement.