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NCT00869661 · ClinicalTrials.gov registry record · Phase 2

A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

A Phase 2 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
413
Enrollment target
20
Study locations

NCT00869661: Completed Phase 2 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

NCT00869661 is a Phase 2 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 413 participants, above the 360-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00869661, a Phase 2 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
413 participants
Enrollment target
20
Study locations

Study Summary

This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG Copegus
  • DRUG Pegasys
  • DRUG RO5024048

Study Locations (20)

California

  • - La Jolla
  • - Sacramento
  • - San Diego
  • - San Francisco

Florida

  • - Bradenton
  • - Gainesville

Texas

  • - Houston
  • - San Antonio

Alabama

  • - Birmingham

District of Columbia

  • - Washington D.C.

Georgia

  • - Marietta

Illinois

  • - Chicago

Maryland

  • - Lutherville

Trial Details

FieldValue
Enrollment Target 413 participants
Start Date 2001-02
Est. Completion 2012-02
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT00869661 record still lists

NCT00869661 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, above the 360-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (15% higher).

The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 3 interventions - of which Copegus is the first listed.

NCT00869661 names 20 study sites across 15 states, led by California, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT00869661 about?

NCT00869661 is a clinical study titled "A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4". This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will rec...

What is the current status of trial NCT00869661?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 413 participants. The study started on 2001-02. Estimated completion is 2012-02.

What conditions does trial NCT00869661 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT00869661?

The interventions under investigation include: Copegus (DRUG), Pegasys (DRUG), RO5024048 (DRUG).

Who is sponsoring clinical trial NCT00869661?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00869661 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hepatitis C, Chronic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00869661's enrollment target sits among peer trials

413 5th of 26 higher than 22 of 26 other Hepatitis C, Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C, Chronic 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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Related registry views

Source: ClinicalTrials.gov NCT00869661, the US trial registry maintained by the National Library of Medicine. NCT00869661 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.