Description:

see http://clinicaltrials.gov/ct2/show/study/NCT00048295 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.

Link:

http://clinicaltrials.gov/ct2/show/study/NCT00048295

Keywords:
Versions (3) ▾
  1. 11/14/11
  2. 11/14/11
  3. 3/22/14
Uploaded on:

March 22, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00048295 Crohns Disease

Eligibility NCT00048295

  1. StudyEvent: Eligibility
    1. Eligibility NCT00048295
Inclusion
[years]
Weight at least 36 kg
CDAI score of 220 - 400
Documentation of Crohns disease activity by endoscopy, biopsy or imaging in the last 2 years
No TNF-alpha inhibitor treatment for three months prior to first study drug infusion
Exclusion
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