An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00355901

Enrollment

300

Registered

2006-07-25

Start date

2006-09-30

Completion date

2012-11-30

Last updated

2008-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis, Colitis, Steroid-Refractory, Visilizumab, Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

Brief summary

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Interventions

DRUGVisilizumab (Nuvion®; HuM291)

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Previous participation in a visilizumab study of IVSR-UC. * Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.

Exclusion criteria

* Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent. * For U.S. sites, unwilling or unable to provide authorization to use protected health information.

Countries

Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026