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Clinical Trials/EUCTR2005-004105-28-GR
EUCTR2005-004105-28-GR
Active, not recruiting
Not Applicable

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

PDL BioPharma, Inc.0 sites300 target enrollmentFebruary 15, 2007
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ConditionsIntravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)MedDRA version: 9.0Level: LLTClassification code 10045365

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
Sponsor
PDL BioPharma, Inc.
Enrollment
300
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 15, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
  • •1\) Previous participation in an IVSR\-UC visilizumab study.
  • •2\) Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\) Unable to understand the purpose and risks of the study, or unwilling or unable to provide signed and dated informed consent.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative ColitisIntravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)MedDRA version: 9.0Level: LLTClassification code 10045365
EUCTR2005-004105-28-NLPDL BioPharma, Inc300
Active, not recruiting
Not Applicable
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S
EUCTR2005-004105-28-DEPDL BioPharma, Inc.300
Active, not recruiting
Not Applicable
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S
EUCTR2005-004105-28-FRPDL BioPharma, Inc.300
Active, not recruiting
Not Applicable
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.
EUCTR2005-004105-28-GBPDL BioPharma, Inc.300
Active, not recruiting
Phase 1
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.
EUCTR2005-004105-28-IEPDL BioPharma, Inc.300