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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00032305
Other study ID # 291-406
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 14, 2002
Last updated March 6, 2012
Start date March 2002
Est. completion date November 2005

Study information

Verified date March 2012
Source Facet Biotech
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.


Description:

A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.

2. Active disease despite ongoing treatment with steroids

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Visilizumab


Locations

Country Name City State
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States The University of Chicago Medical Center Chicago Illinois
United States Cedars-Sinai Medical Center Los Angeles California
United States Mount Sinai School of Medicine New York New York
United States University of Pittsburgh School of Medicine Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States University of California San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Facet Biotech

Country where clinical trial is conducted

United States, 

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