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NCT00274495 · ClinicalTrials.gov registry record · Phase 4
Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver
A Phase 4 study, sponsored by Beth Israel Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00274495 is a Phase 4 study that was terminated before completion, run by Beth Israel Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT00274495, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with standard therapy. Standard therapy consists of weekly pegylated interferon injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype 1 patients is effective in only 45% of patients at best. In addition, this therapy must be given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone to the standard therapy in genotype 1 patients with fatty liver disease will increase effectiveness of the standard therapy of hepatitis C.
Interventions
- DRUG Rosiglitazone and Pegasys/Ribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00274495
The ClinicalTrials.gov registry entry for NCT00274495 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rosiglitazone and Pegasys/Ribavirin is the first listed.
NCT00274495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00274495 about?
NCT00274495 is a clinical study titled "Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver". To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with standard therapy. Standard therapy consists of weekly pegylated interferon injections and daily rib...
What is the current status of trial NCT00274495?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2006-01. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00274495?
The interventions under investigation include: Rosiglitazone and Pegasys/Ribavirin (DRUG).
Who is sponsoring clinical trial NCT00274495?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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