DRUG
Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
Status
Completed
Phase
Phase 2
Enrollment
67
Locations
24
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 29, 2006
Study start
Mar 1, 2004
Primary completion
Nov 1, 2005
Study completion
Jun 1, 2006
Results posted
Not reported
Registry updated
May 14, 2021
Outcomes
What the study measures.
Primary outcomes
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
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Study locations
24 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Advanced Clinical Therapeutics
Tucson, Arizona, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States
Rx Trials
Washington D.C., District of Columbia, United States
Clinical Trials Management of Boca Raton
Boca Raton, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Venture Research
North Miami Beach, Florida, United States
Pinnacle Trials
Atlanta, Georgia, United States
Saint Joseph's Health System
Atlanta, Georgia, United States
Northwestern University School of Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Asher Kornbluth, MD, PC
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Atilla Ertan
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
McGuire DVAMC
Richmond, Virginia, United States
Dean Foundation Research Center
Madison, Wisconsin, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Center
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, Canada
Life Screening Centres
Toronto, Ontario, Canada
Publications
Results and literature.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.