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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00355901




Registration number
NCT00355901
Ethics application status
Date submitted
21/07/2006
Date registered
25/07/2006
Date last updated
5/08/2008

Titles & IDs
Public title
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
Scientific title
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
Secondary ID [1] 0 0
291-420
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Visilizumab (Nuvion®; HuM291)

Treatment: Drugs: Visilizumab (Nuvion®; HuM291)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Fremantle
Recruitment hospital [4] 0 0
- Liverpool
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
6160 - Fremantle
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Belgium
State/province [14] 0 0
Ghent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Roeselare
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Brno
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Praha
Country [21] 0 0
France
State/province [21] 0 0
Amiens Cedex
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg
Country [25] 0 0
Hungary
State/province [25] 0 0
Béri Balogh Adám
Country [26] 0 0
Hungary
State/province [26] 0 0
Vac
Country [27] 0 0
Hungary
State/province [27] 0 0
Vásvari Pál
Country [28] 0 0
Ireland
State/province [28] 0 0
Dublin
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
Norway
State/province [31] 0 0
Oslo
Country [32] 0 0
Norway
State/province [32] 0 0
Tromso
Country [33] 0 0
Ukraine
State/province [33] 0 0
Kharkov

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PDL BioPharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00355901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00355901