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NCT00394277 · ClinicalTrials.gov registry record · Phase 4
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,175
- Enrollment target
NCT00394277: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00394277 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,175 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00394277, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,175 participants
- Enrollment target
Study Summary
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Primary Outcome
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477).
Interventions
- DRUG Ribavirin
- DRUG peginterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,175 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00394277 record still lists
NCT00394277 is an interventional study that assigns participants to a tested intervention. Its 1,175 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (127% higher).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT00394277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00394277 about?
NCT00394277 is a clinical study titled "A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C". This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) ge...
What is the current status of trial NCT00394277?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,175 participants. The study started on 2007-02. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00394277?
The interventions under investigation include: Ribavirin (DRUG), peginterferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00394277?
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 NCT00394277's enrollment target sits among peer trials
1,175 63rd of 2000 higher than 1,938 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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