Trials / Completed
CompletedNCT00168038
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10\^9/L.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immunoglobulin Intravenous (Human) | A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw. |
Timeline
- Start date
- 2004-12-01
- Completion
- 2006-02-01
- First posted
- 2005-09-14
- Last updated
- 2011-11-23
- Results posted
- 2011-11-23
Locations
17 sites across 6 countries: Germany, Italy, Poland, Russia, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00168038. Inclusion in this directory is not an endorsement.