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NCT00545233 · ClinicalTrials.gov registry record · Phase 4
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 155
- Enrollment target
NCT00545233 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 155 participants.
The verdict
NCT00545233, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 155 participants
- Enrollment target
Study Summary
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Interventions
- DRUG Pioglitazone
- DRUG ribavirin [Copegus]
- DRUG peginterferon alfa-2a [Pegasys]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00545233
The ClinicalTrials.gov registry entry for NCT00545233 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pioglitazone is the first listed.
NCT00545233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00545233 about?
NCT00545233 is a clinical study titled "A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.". This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 mic...
What is the current status of trial NCT00545233?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 155 participants. The study started on 2008-01. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00545233?
The interventions under investigation include: Pioglitazone (DRUG), ribavirin [Copegus] (DRUG), peginterferon alfa-2a [Pegasys] (DRUG).
Who is sponsoring clinical trial NCT00545233?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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