Ulcerative ColitisNCT00355901
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
An observational study of Ulcerative Colitis, run by PDL BioPharma, Inc. at 40 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Visilizumab (Nuvion®; HuM291)
- How many people
- 300 participants
- Where
- 40 sitesin 14 countries
- Study dates
- Sep 2006to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous participation in a visilizumab study of IVSR-UC.
- Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 14 countries.
40 sites in 14 countries
United States15 sites
Study site
Atlanta, Georgia, 30342
Study site
Charleston, South Carolina, 29425
Study site
Cleveland, Ohio, 44106
Study site
Gainesville, Florida, 32610
Study site
Hershey, Pennsylvania, 17033
Study site
Louisville, Kentucky, 40202
Study site
Manhasset, New York, 11030
Study site
Mineola, New York, 11501
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
Rochester, Minnesota, 55905
Study site
Salt Lake City, Utah, 84107
Study site
San Francisco, California, 94115
Study site
St Louis, Missouri, 63110
Study site
Worcester, Massachusetts, 01655
Australia4 sites
Study site
Bedford Park, South Australia
Study site
Box Hill, Victoria
Study site
Fremantle, 6160
Study site
Liverpool, 2170
Belgium3 sites
Study site
Ghent, B-9000
Study site
Leuven, 3000
Study site
Roeselare, 8800
France3 sites
Study site
Amiens, 80054
Study site
Lille, 59037
Study site
Paris, 75010
Hungary3 sites
Study site
Béri Balogh Adám, H-7100
Study site
Vác, H-2601
Study site
Vásvari Pál, H-9024
Canada2 sites
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Winnipeg, Manitoba, R3A-139
About this study
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Visilizumab (Nuvion®; HuM291)
- Keywords
- Ulcerative Colitis, Colitis, Steroid-Refractory, Visilizumab, Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
- Medical subject headings
- Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visilizumab (Nuvion®; HuM291)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startSep 2006
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PDL BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355901
- Sponsor's protocol ID
- 291-420
- Status last verified
- Aug 2008
- First submitted
- 21 Jul 2006
- Last updated
- 5 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00355901
- Acronym / sponsor ID
- 291-420
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Colitis, Steroid-Refractory, Visilizumab, Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PDL BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Nov 2012
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous participation in a visilizumab study of IVSR-UC.
- Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visilizumab (Nuvion®; HuM291) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by PDL BioPharma, Inc. at 40 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Australia, Belgium, France, Hungary and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2008.