Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
- Registration Number
- NCT00308438
- Lead Sponsor
- Shire
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
-
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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Teduglutide (ALX-0600) All subjects in the study dosed at 0.1 mg/kg teduglutide
- Primary Outcome Measures
Name Time Method The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study. 12 weeks after start of study
- Secondary Outcome Measures
Name Time Method 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. 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 12 weeks after study start
Trial Locations
- Locations (24)
Clinical Trials Management of Boca Raton
🇺🇸Boca Raton, Florida, United States
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Venture Research
🇺🇸North Miami Beach, Florida, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Asher Kornbluth, MD, PC
🇺🇸New York, New York, United States
Dean Foundation Research Center
🇺🇸Madison, Wisconsin, United States
Life Screening Centres
🇨🇦Toronto, Ontario, Canada
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
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Queen Elizabeth II Health Sciences
🇨🇦Halifax, Nova Scotia, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Rx Trials
🇺🇸Washington, District of Columbia, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Atilla Ertan
🇺🇸Houston, Texas, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States