A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

NCT ID: NCT00502294

Last Updated: 2009-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.

Detailed Description

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Conditions

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Intravenous Steroid-Refractory Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Visilizumab (HuM291; Nuvion®)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females, 18 years of age or older.
* Diagnosis of UC verified by endoscopy within 60 months prior to consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PDL BioPharma, Inc.

INDUSTRY

Sponsor Role collaborator

Facet Biotech

INDUSTRY

Sponsor Role lead

Other Identifiers

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291-416

Identifier Type: -

Identifier Source: org_study_id

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