Trials / Completed
CompletedNCT01218438
Phase 2/3 Study of IGSC, 20% in PIDD
A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immune Globulin Intravenous (Human), 10% Solution | Intravenous infusion with IGIV, 10% |
| DRUG | Immune Globulin Subcutaneous (Human), 20% Solution | Subcutaneous infusion with IGSC, 20% |
Timeline
- Start date
- 2013-01-28
- Primary completion
- 2015-03-13
- Completion
- 2015-03-13
- First posted
- 2010-10-11
- Last updated
- 2021-07-20
- Results posted
- 2017-02-15
Locations
18 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01218438. Inclusion in this directory is not an endorsement.