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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: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00545233 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 155 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
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 |
What the finished NCT00545233 record still lists
NCT00545233 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Pioglitazone is the first listed.
NCT00545233 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00545233's enrollment target sits among peer trials
155 525th of 2000 higher than 1,473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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