Crohn's DiseasePhase 2NCT00308438
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
A Phase 2 study testing Teduglutide (ALX-0600) in people with Crohn's Disease, run by Shire at 24 sites in 2 countries.
Trial summary
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Teduglutide (ALX-0600)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 1 Mar 2004to 1 Jun 2006
- Phase
- Phase 2
- 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
- Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
- Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
- CDAI score greater than 220
- Stool samples not required
- C-reactive protein levels are not an exclusion criterion
Who cannot join
- Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
- Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States20 sites
Pinnacle Trials
Atlanta, Georgia, 30329
Saint Joseph's Health System
Atlanta, Georgia, 30342
Clinical Trials Management of Boca Raton
Boca Raton, Florida, 33486
Northwestern University School of Medicine
Chicago, Illinois, 60619
University of Chicago
Chicago, Illinois, 60637
Clinical Research of West Florida
Clearwater, Florida, 33765
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Long Island Clinical Research Associates
Great Neck, New York, 11021
Atilla Ertan
Houston, Texas, 77005
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80401
University of Louisville
Louisville, Kentucky, 40202
Dean Foundation Research Center
Madison, Wisconsin, 53715
Asher Kornbluth, MD, PC
New York, New York, 10128
Venture Research
North Miami Beach, Florida, 33162
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Wake Research Associates
Raleigh, North Carolina, 27612
McGuire DVAMC
Richmond, Virginia, 23249
University of Utah
Salt Lake City, Utah, 84132
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Rx Trials
Washington D.C., District of Columbia, 20010
Canada4 sites
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, B3H 1V7
Life Screening Centres
Toronto, Ontario, M5S 2A5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L5
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
Read the detailed description
The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.
- Conditions
- Crohn's Disease
- Being tested
- Teduglutide (ALX-0600)
- Keywords
- Crohn Disease, Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teduglutide (ALX-0600)Drug
Also called teduglutide
0.1 mg/kg injected subcutaneously daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects in the study dosed at 0.1 mg/kg teduglutide Receives: Drug: Teduglutide (ALX-0600) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.
Measured: 12 weeks after start of study
Secondary outcomes (2)
The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved.
Measured: 12 weeks after study start
The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study
Measured: 12 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study start1 Mar 2004
- Primary completion1 Nov 2005
- Study completion1 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308438
- Sponsor's protocol ID
- CL0600-009
- Status last verified
- May 2021
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.
PubMed 19821509
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008
- ClinicalTrials.gov ID
- NCT00308438
- Acronym / sponsor ID
- CL0600-009
- Conditions
- Crohn's Disease
- Keywords
- Crohn Disease, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 1 Nov 2005 (actual)
- Study completion
- 1 Jun 2006 (actual)
- First posted
- 29 Mar 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.
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
Detailed description
The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Teduglutide (ALX-0600)All subjects in the study dosed at 0.1 mg/kg teduglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
- Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
Key exclusion criteria (2 listed)
- Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
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 |
|---|---|---|
| Teduglutide (ALX-0600)Also: teduglutide0.1 mg/kg injected subcutaneously daily | Drug | 1 |
Primary outcome
The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.
Time frame: 12 weeks after start of study
2 secondary outcomes
The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved.
Time frame: 12 weeks after study start
The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study
Time frame: 12 weeks after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Background: PubMed 19821509Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.
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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.
Study Director study director
Takeda
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teduglutide (ALX-0600) in people with Crohn's Disease, run by Shire at 24 sites in 2 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 5 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: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study. (time frame: 12 weeks after start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308438, which also lists 1 linked publication.
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 14 May 2021.