Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
NCT ID: NCT00048113
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2001-01-10
2002-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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Alicaforsen
Eligibility Criteria
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Inclusion Criteria
2. Weight \>/= 36 kg
3. CDAI score of 220 - 400
4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years
5. No TNF-α inhibitor treatment for three months prior to first study drug infusion
Exclusion Criteria
2. Extensive external fistulization (\> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
3. Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
4. Malignancy within 3 years or poorly controlled medical illness
5. Requires intravenous heparin therapy or with a history of a bleeding problem
12 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Locations
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Little Rock, Arkansas, United States
Orange, California, United States
San Diego, California, United States
Arvada, Colorado, United States
Jacksonville, Florida, United States
Winter Park, Florida, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Detroit, Michigan, United States
Mexico, Missouri, United States
Lincoln, Nebraska, United States
Buffalo, New York, United States
Rochester, New York, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Hamilton, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Québec, , Canada
Countries
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Related Links
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Type "ISIS 2302" in search box
Other Identifiers
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ISIS 2302-CS20
Identifier Type: -
Identifier Source: org_study_id
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