A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients.

INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment with a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) with or without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients. - INFORM-SVR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022067-35-DE

Enrollment

200

Registered

2010-11-23

Start date

2011-02-17

Completion date

Unknown

Last updated

2013-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C (CHC) Genotype 1 (Arms A and B) and Genotypes 1b and 4 (Arm C) MedDRA version: 15.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: N.A. Product Code: RO5024048/ F11 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N.A. Current Sponsor code: RO5024048 Other descriptive name: Mericitabine, HCV Polymerase I

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To establish the safety, tolerability and efficacy (SVR24) of up to 24 weeks of treatment with an IFN-free regimen of RO5024048 and DNV/r, with or without RBV in interferon naïve CHC genotype 1 patients ;Secondary Objective: • To establish the antiviral activity (RVR, EOT, SVR12) of up to 24 weeks of treatment with an IFN-free regimen of RO5024048 and DNV/r, with or without RBV • To determine the impact of RBV on safety, tolerability and antiviral activity of the direct acting antiviral combination regimen • To compare 12 or 24 weeks duration on safety, tolerability and antiviral activity of the direct acting antiviral combination regimens • To evaluate the pharmacokinetics/pharmacodynamics of RO5024048, DNV/r and RBV when co-administered • To characterize drug resistance when RO5024048 and DNV/r are co-administered in the presence or absence of RBV • To assess the effect of IL28b genotype on treatment efficacy • To assess the effect of IFN-free treatment on patient reported quality of life measures;Primary end point(s): 1. Sustained virological response, defined as undetectable HCV RNA measured by Roche COBAS TaqMan HCV test 2. Safety: Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1. 24 weeks after end of treatment 2. 1.5 years	—

Measure

Time frame

Main Objective: • To establish the safety, tolerability and efficacy (SVR24) of up to 24 weeks of treatment with an IFN-free regimen of RO5024048 and DNV/r, with or without RBV in interferon naïve CHC genotype 1 patients ;Secondary Objective: • To establish the antiviral activity (RVR, EOT, SVR12) of up to 24 weeks of treatment with an IFN-free regimen of RO5024048 and DNV/r, with or without RBV • To determine the impact of RBV on safety, tolerability and antiviral activity of the direct acting antiviral combination regimen • To compare 12 or 24 weeks duration on safety, tolerability and antiviral activity of the direct acting antiviral combination regimens • To evaluate the pharmacokinetics/pharmacodynamics of RO5024048, DNV/r and RBV when co-administered • To characterize drug resistance when RO5024048 and DNV/r are co-administered in the presence or absence of RBV • To assess the effect of IL28b genotype on treatment efficacy • To assess the effect of IFN-free treatment on patient reported quality of life measures;Primary end point(s): 1. Sustained virological response, defined as undetectable HCV RNA measured by Roche COBAS TaqMan HCV test 2. Safety: Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1. 24 weeks after end of treatment 2. 1.5 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Virological response (HCV RNA measured by Roche COBAS Taqman HCV test) 2. Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) 3. Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) 4. Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin 5. Viral resistance: HCV RNA sequencing and phenotypic analyses 6. Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) 7. Quality of life: SF-36 questionnaire, Fatigue Severity Scale;Timepoint(s) of evaluation of this end point: 1. up to 48 weeks 2. 1.5 years 3. 1.5 years 4. up to 24 weeks 5. up to 48 weeks 6. 1.5 years 7. up to 36 weeks	—

Measure

Time frame

Secondary end point(s): 1. Virological response (HCV RNA measured by Roche COBAS Taqman HCV test) 2. Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) 3. Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) 4. Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin 5. Viral resistance: HCV RNA sequencing and phenotypic analyses 6. Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) 7. Quality of life: SF-36 questionnaire, Fatigue Severity Scale;Timepoint(s) of evaluation of this end point: 1. up to 48 weeks 2. 1.5 years 3. 1.5 years 4. up to 24 weeks 5. up to 48 weeks 6. 1.5 years 7. up to 36 weeks

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Countries

France, Germany, New Zealand, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026