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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 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.

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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

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00869661

The ClinicalTrials.gov registry entry for NCT00869661 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 360-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (15% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.