Trials / Completed
CompletedNCT00542997
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 2 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
Detailed description
This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy period. During the 28-week efficacy period, subjects visited the study site at least every 4 weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28 ± 1).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator. |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2007-10-12
- Last updated
- 2011-09-01
- Results posted
- 2011-03-15
Locations
19 sites across 9 countries: France, Germany, Italy, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00542997. Inclusion in this directory is not an endorsement.