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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.

NCT ID: NCT00377182

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PEGASYS with COPEGUS

Group Type ACTIVE_COMPARATOR

Copegus

Intervention Type DRUG

1000/1200mg po daily for 4 weeks

PEGASYS

Intervention Type DRUG

180 micrograms sc weekly for 4 weeks

RO5024048 1500mg in combination with PEGASYS

Group Type EXPERIMENTAL

PEGASYS

Intervention Type DRUG

180 micrograms sc weekly for 4 weeks

RO5024048 1500mg

Intervention Type DRUG

1500mg po bid for 4 weeks

RO5024048 3000mg in combination with PEGASYS

Group Type EXPERIMENTAL

PEGASYS

Intervention Type DRUG

180 micrograms sc weekly for 4 weeks

RO5024048 3000mg

Intervention Type DRUG

3000mg po bid for 4 weeks

RO5024048 in combination with PEGASYS and COPEGUS

Group Type EXPERIMENTAL

Copegus

Intervention Type DRUG

1000/1200mg po daily for 4 weeks

PEGASYS

Intervention Type DRUG

180 micrograms sc weekly for 4 weeks

RO5024048 1500mg

Intervention Type DRUG

1500mg po bid for 4 weeks

Interventions

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Copegus

1000/1200mg po daily for 4 weeks

Intervention Type DRUG

PEGASYS

180 micrograms sc weekly for 4 weeks

Intervention Type DRUG

RO5024048 1500mg

1500mg po bid for 4 weeks

Intervention Type DRUG

RO5024048 3000mg

3000mg po bid for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-65 years of age;
* CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
* chronic liver disease consistent with CHC.

Exclusion Criteria

* infection with any HCV genotype other than genotype 1;
* previous treatment for CHC;
* medical condition associated with chronic liver disease other than CHC;
* HIV, Hepatitis A, Hepatitis B infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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La Jolla, California, United States

Site Status

Long Beach, California, United States

Site Status

Sacramento, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

San Francisco, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Bradenton, Florida, United States

Site Status

Gainesville, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Novi, Michigan, United States

Site Status

Manhasset, New York, United States

Site Status

New York, New York, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Dallas, Texas, United States

Site Status

Fort Sam Houston, Texas, United States

Site Status

Richmond, Virginia, United States

Site Status

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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PV18369

Identifier Type: -

Identifier Source: org_study_id