Trials / Completed
CompletedNCT01199705
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immune Globulin Subcutaneous (Human) (SCIG) | IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-08-01
- Completion
- 2011-11-01
- First posted
- 2010-09-13
- Last updated
- 2014-12-12
- Results posted
- 2013-03-20
Locations
10 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01199705. Inclusion in this directory is not an endorsement.