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NCT00308438 Clinical Trial

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00308438
Other study ID # CL0600-009
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 1, 2004
Est. completion date June 1, 2006

Study information
Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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 information / eligibility
Status Completed
Enrollment 67
Est. completion date June 1, 2006
Est. primary completion date November 1, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily

Locations
Country Name City State
Canada Queen Elizabeth II Health Sciences Halifax Nova Scotia
Canada Life Screening Centres Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Canada Health Sciences Center Winnipeg Manitoba
United States Pinnacle Trials Atlanta Georgia
United States Saint Joseph's Health System Atlanta Georgia
United States Clinical Trials Management of Boca Raton Boca Raton Florida
United States Northwestern University School of Medicine Chicago Illinois
United States University of Chicago Chicago Illinois
United States Clinical Research of West Florida Clearwater Florida
United States Cleveland Clinic Foundation Cleveland Ohio
United States Long Island Clinical Research Associates Great Neck New York
United States Atilla Ertan Houston Texas
United States Rocky Mountain Gastroenterology Lakewood Colorado
United States University of Louisville Louisville Kentucky
United States Dean Foundation Research Center Madison Wisconsin
United States Asher Kornbluth, MD, PC New York New York
United States Venture Research North Miami Beach Florida
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Wake Research Associates Raleigh North Carolina
United States McGuire DVAMC Richmond Virginia
United States University of Utah Salt Lake City Utah
United States Advanced Clinical Therapeutics Tucson Arizona
United States Rx Trials Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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