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NCT00048113 · ClinicalTrials.gov registry record · Phase 3
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
A Phase 3 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT00048113 is a Phase 3 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 150 participants.
The verdict
NCT00048113, a Phase 3 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Alicaforsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2001-01-10 |
| Est. Completion | 2002-04-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048113
The ClinicalTrials.gov registry entry for NCT00048113 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alicaforsen is the first listed.
NCT00048113 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048113 about?
NCT00048113 is a clinical study titled "Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease". 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...
What is the current status of trial NCT00048113?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2001-01-10. Estimated completion is 2002-04-27.
What interventions are being tested in trial NCT00048113?
The interventions under investigation include: Alicaforsen (DRUG).
Who is sponsoring clinical trial NCT00048113?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
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