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NCT00087646 · ClinicalTrials.gov registry record · Phase 4
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 948
- Enrollment target
NCT00087646: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00087646 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 948 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00087646, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 948 participants
- Enrollment target
Study Summary
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Primary Outcome
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.
Interventions
- DRUG Ribavirin
- DRUG peginterferon alfa-2a [Pegasys]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 948 participants |
| Start Date | 2003-09 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
What the finished NCT00087646 record still lists
NCT00087646 is an interventional study that assigns participants to a tested intervention. The registered 948 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT00087646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00087646 about?
NCT00087646 is a clinical study titled "REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy". This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), a...
What is the current status of trial NCT00087646?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 948 participants. The study started on 2003-09. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00087646?
The interventions under investigation include: Ribavirin (DRUG), peginterferon alfa-2a [Pegasys] (DRUG).
Who is sponsoring clinical trial NCT00087646?
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 NCT00087646's enrollment target sits among peer trials
948 78th of 2000 higher than 1,922 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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