A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]; Drug: RO5024048; Drug: ribavirin [Copegus]; Drug: Copegus placebo; Drug: danoprevir; Drug: ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278134

PP25213

2010-022067-35

Details and patient eligibility

About

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient, >/= 18 years of age
• Chronic Hepatitis C of >/= 6 months duration at screening
• HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
• Naïve for treatment with interferon (pegylated or non-pegylated)
• Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
• Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception

Exclusion criteria

• Pregnant or lactating women and males with female partners who are pregnant or lactating
• Decompensated liver disease or impaired liver function
• Cirrhosis or incomplete/transition to cirrhosis
• Non-hepatitis C chronic liver disease
• Hepatitis B or HIV infection
• History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
• History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
• History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 3 patient groups

Arm B Extension

Experimental group

Description:

All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.

Treatment:

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]

RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B)

Experimental group

Treatment:

Drug: Copegus placebo

Drug: danoprevir

Drug: ritonavir

Drug: RO5024048

RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A)

Experimental group

Treatment:

Drug: ribavirin [Copegus]

Drug: danoprevir

Drug: ritonavir

Drug: RO5024048