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

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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.

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.

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
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5458 Town Center Rd # 19
Boca Raton, Florida 33486
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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Atlanta, Georgia 30329
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Atlanta, Georgia 30342
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Great Neck, New York 11021
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Houston, Texas 77005
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Lakewood, Colorado 80214
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Madison, Wisconsin 53715
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New York, New York 10128
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16853 Northeast 2nd Avenue
North Miami Beach, Florida 33162
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
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Richmond, Virginia 23249
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Tucson, Arizona 85712
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Washington, District of Columbia 20010
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