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
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University of Chicago One of the world's premier academic and research institutions, the University of...
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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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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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