Trials / Completed
CompletedNCT00430898
Basiliximab in Moderate to Severe Ulcerative Colitis
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 181 (estimated)
- Sponsor
- Cerimon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Basiliximab | 3 doses of 40mg, IV at baseline, week 2, and week 4 |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2007-02-02
- Last updated
- 2008-12-18
Locations
68 sites across 9 countries: United States, Belgium, Czechia, India, Poland, Russia, Slovakia, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00430898. Inclusion in this directory is not an endorsement.