Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/21/2017 |
| Start Date: | March 1, 2004 |
| End Date: | June 1, 2006 |
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.
safe and effective in treating Crohn's Disease.
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.
into your abdomen or thigh. There are a total of five visits.
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.
We found this trial at
21
sites
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Utah Research is a major component in the life of the U benefiting...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Louisville The University of Louisville is a state supported research university located in...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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