Alicaforsen (ISIS 2302) in Patients With Active Crohn’s Disease
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ClinicalTrials.gov Identifier: NCT00048295
Recruitment Status : Unknown
Verified April 2004 by Ionis Pharmaceuticals, Inc.. Recruitment status was: Active, not recruiting
ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn’s disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the “instruction” molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age >/= 12 years
Weight >/= 36 kg
CDAI score of 220 – 400
Documentation of Crohn’s disease activity by endoscopy, biopsy or imaging in the last 2 years
No TNF-α inhibitor treatment for three months prior to first study drug infusion
Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
Malignancy within 3 years or poorly controlled medical illness
Requires intravenous heparin therapy or with a history of a bleeding problem