A research study of a new medicine, danoprevir, with ritonavir and Copegus (also known as ribavirin), in combination with another new medicine, RO5024048, and/or Pegasys for the treatment of a disease called chronic hepatitis C, which causes damage to the liver, in patients that failed a previous treatment for hepatitis C.

A Randomized, Open-label, Multicenter Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (Danoprevir/r) and Copegus®, in Combination with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or Pegasys® in Chronic Hepatitis C Genotype 1 Patients Who Failed with a Previous Course of Peginterferon alfa plus Ribavirin Combination Therapy - Matterhorn

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019585-90-AT

Enrollment

420

Registered

2011-02-24

Start date

2011-05-05

Completion date

Unknown

Last updated

2013-03-04

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

Conditions

Chronic Hepatitis C MedDRA version: 14.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Danoprevir Product Code: RO5190591/F24 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Danoprevir Current Sponsor code: RO5190591 Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients, age 18 years and older - Presence of hepatitis C infection, genotype 1a or 1b - Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks - Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start 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 395 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b - Patients with cirrhosis - Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response - Co-infection with hepatitis B or human immunodeficiency virus (HIV) - History or evidence of chronic liver disease other than hepatitis C

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the sustained virological response of the following treatment regimens: - DNV/r with RO5024048 and Copegus® when administered for 24 weeks in patients with previous partial or null response to PEG-IFN/RBV treatment. - DNV/r with Pegasys® and Copegus® when administered for 24 weeks in patients with previous partial response to PEG-IFN/RBV treatment. - DNV/r and RO5024048 with Pegasy®s and Copegus® when administered for 24 weeks in patients with previous partial or null response to PEG-IFN/RBV treatment. - DNV/r and RO5024048 with Pegasys® and Copegus® when administered for 24 weeks followed by Pegasys® and Copegus® administered for an additional 24 weeks in patients with previous null response to PEG-IFN/RBV treatment.;Secondary Objective: - To compare the safety (incidence of adverse events) of the following treatment regimens: danoprevir, RO5024048 and Copegus; danoprevir, Pegasys and Copegus; danoprevir, RO5024048, Pegasys and Copegus. - To determine virologic response over time - To characterize the pharmacokinetics of DNV and RO5024048 - To characterize the resistance profile of DNV and RO5024048;Primary end point(s): The primary measure of efficacy is SVR-24 according to planned treatment duration.;Timepoint(s) of evaluation of this end point: 24 weeks after the planned end of treatment	—

Measure

Time frame

Main Objective: To compare the sustained virological response of the following treatment regimens: - DNV/r with RO5024048 and Copegus® when administered for 24 weeks in patients with previous partial or null response to PEG-IFN/RBV treatment. - DNV/r with Pegasys® and Copegus® when administered for 24 weeks in patients with previous partial response to PEG-IFN/RBV treatment. - DNV/r and RO5024048 with Pegasy®s and Copegus® when administered for 24 weeks in patients with previous partial or null response to PEG-IFN/RBV treatment. - DNV/r and RO5024048 with Pegasys® and Copegus® when administered for 24 weeks followed by Pegasys® and Copegus® administered for an additional 24 weeks in patients with previous null response to PEG-IFN/RBV treatment.;Secondary Objective: - To compare the safety (incidence of adverse events) of the following treatment regimens: danoprevir, RO5024048 and Copegus; danoprevir, Pegasys and Copegus; danoprevir, RO5024048, Pegasys and Copegus. - To determine virologic response over time - To characterize the pharmacokinetics of DNV and RO5024048 - To characterize the resistance profile of DNV and RO5024048;Primary end point(s): The primary measure of efficacy is SVR-24 according to planned treatment duration.;Timepoint(s) of evaluation of this end point: 24 weeks after the planned end of treatment

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Secondary

Measure	Time frame
Secondary end point(s): - SVR-24 according to actual treatment duration, defined as the percentage of patients with undetectable HCV RNA 20 weeks after the actual end of treatment, as measured by Roche COBAS TaqMan HCV. - Virological response at clinical visits over time, defined as the percentage of patients with undetectable ( 0.5 log10 followed by an increase of at least 0.5 log10 from on treatment nadir) before the end of danoprevir/r or RO5024058 treatment.;Timepoint(s) of evaluation of this end point: 24 weeks after the planned end of treatment. Up to four interim analyses of efficacy and safety data may be performed to inform the clinical development plan for RO5024048 and danoprevir. Interim analyses may be performed (1) when at least 80% of patients have completed approximately 12 weeks in the study, (2) when all patients have completed at least 24 weeks in the study, (3) when all patients have completed at least 36 weeks in the study, and (4) when all patients have completed at least 12 weeks of treatment-free follow up.	—

Measure

Time frame

Secondary end point(s): - SVR-24 according to actual treatment duration, defined as the percentage of patients with undetectable HCV RNA 20 weeks after the actual end of treatment, as measured by Roche COBAS TaqMan HCV. - Virological response at clinical visits over time, defined as the percentage of patients with undetectable ( 0.5 log10 followed by an increase of at least 0.5 log10 from on treatment nadir) before the end of danoprevir/r or RO5024058 treatment.;Timepoint(s) of evaluation of this end point: 24 weeks after the planned end of treatment. Up to four interim analyses of efficacy and safety data may be performed to inform the clinical development plan for RO5024048 and danoprevir. Interim analyses may be performed (1) when at least 80% of patients have completed approximately 12 weeks in the study, (2) when all patients have completed at least 24 weeks in the study, (3) when all patients have completed at least 36 weeks in the study, and (4) when all patients have completed at least 12 weeks of treatment-free follow up.

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Countries

Australia, Austria, Brazil, Canada, France, Germany, Italy, Mexico, Poland, Spain, United Kingdom, 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