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NCT00377182 · ClinicalTrials.gov registry record · Phase 2
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT00377182 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 107 participants.
The verdict
NCT00377182, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study Summary
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Interventions
- DRUG Copegus
- DRUG PEGASYS
- DRUG RO5024048 1500mg
- DRUG RO5024048 3000mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00377182
The ClinicalTrials.gov registry entry for NCT00377182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 107 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 4 interventions - of which Copegus is the first listed.
NCT00377182 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00377182 about?
NCT00377182 is a clinical study titled "A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.". This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po ...
What is the current status of trial NCT00377182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2006-09. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00377182?
The interventions under investigation include: Copegus (DRUG), PEGASYS (DRUG), RO5024048 1500mg (DRUG), RO5024048 3000mg (DRUG).
Who is sponsoring clinical trial NCT00377182?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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