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NCT00267306 · ClinicalTrials.gov registry record · Phase 1
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
A Phase 1 study, sponsored by Facet Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
NCT00267306 is a Phase 1 study that has completed, run by Facet Biotech. The registered enrollment target is 144 participants.
The verdict
NCT00267306, a Phase 1 study, has completed, sponsored by Facet Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. What is visilizumab? Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis. Who can participate in this study? The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics: * 16-70 year olds * A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry * Active disease despite ongoing treatment with steroids How is this study conducted? Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work. How does one get more information? This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.
Interventions
- DRUG Visilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00267306
The ClinicalTrials.gov registry entry for NCT00267306 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Facet Biotech, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Visilizumab is the first listed.
NCT00267306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00267306 about?
NCT00267306 is a clinical study titled "Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis". The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. What is visilizumab? Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally m...
What is the current status of trial NCT00267306?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2004-01. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00267306?
The interventions under investigation include: Visilizumab (DRUG).
Who is sponsoring clinical trial NCT00267306?
This trial is sponsored by Facet Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
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