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

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Key facts

Study ID

NCT00308438

Run by

Shire

People needed

67

Starts

2004-03-01

Expected to finish

2006-06-01

Last updated by the study team

2021-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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