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.

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Copegus; Drug: RO5024048 3000mg; Drug: PEGASYS; Drug: RO5024048 1500mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377182

PV18369

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 4 patient groups

PEGASYS with COPEGUS

Active Comparator group

Treatment:

Drug: PEGASYS

Drug: Copegus

RO5024048 1500mg in combination with PEGASYS

Experimental group

Treatment:

Drug: RO5024048 1500mg

Drug: PEGASYS

RO5024048 3000mg in combination with PEGASYS

Experimental group

Treatment:

Drug: RO5024048 3000mg

Drug: PEGASYS

RO5024048 in combination with PEGASYS and COPEGUS

Experimental group

Treatment:

Drug: RO5024048 1500mg

Drug: PEGASYS

Drug: Copegus