Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,175 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00394277
The ClinicalTrials.gov registry entry for NCT00394277 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,175 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 2 interventions - of which Ribavirin is the first listed.
NCT00394277 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.