NCT00502294

WithdrawnPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Mul...

Facet Biotech Source

Facet Biotech

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

291-416

Study Type

interventional

Estimated enrollment

150

Locations

0 countries

Sites

N/A

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Estimated enrollment: 150 participants
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 13, 2007
Actual (reported)
First Posted
July 17, 2007
Actual (reported)

Last Updated: June 25, 2009
Status Verified: July 2008
Last Update Submitted: June 23, 2009

Conditions

Intravenous Steroid-Refractory Ulcerative Colitis

Keywords

Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC

Interventions

Visilizumab (HuM291; Nuvion®)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

PDL BioPharma, Inc.
Industrycollaborator
Facet Biotech
Industrylead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

visilizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Last Updated

June 25, 2009

Record last verified: 2008-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00502294
Data provider: ClinicalTrials.gov
Source updated: 2009-06-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:58 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record