A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment

November 1, 2016 updated by: Hoffmann-La Roche
This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Hepatitis C genotype 1 infection
  • Serum HCV quantifiable by Roche COBAS TaqMan HCV Test v2.0
  • Liver biopsy (within 24 months) or Fibroscan (within 12 months) before first administration of study drug consistent with chronic hepatitis C and demonstrating absence of liver cirrhosis
  • Documented failed prior treatment with protease inhibitor (evidenced by viral breakthrough or partial response while on treatment or relapse after treatment), including documentation on treatment with other direct-acting antiviral agents and other HCV antiviral treatment
  • Patients must have discontinued prior HCV treatment at least 24 weeks prior to first dose of study drug in this trial

Exclusion Criteria:

  • Infection with any HCV genotype other than genotype 1
  • Evidence of any variants associated with protease inhibitor resistance at screening
  • Body mass index (BMI) <18 or >/=36 kg/m2
  • Positive for hepatitis A or hepatitis B infection
  • Use of any systemic antiviral therapy with perceived activity against HCV </=1 month prior to first dose of study drug
  • History or evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
  • Pregnant or breastfeeding women
  • Males with female partners who are pregnant
  • History of immunologically mediated disease; patients with rheumatoid arthritis requiring only intermittent non-steroidal anti-inflammatory medications or with celiac disease will be allowed
  • History or evidence of decompensated liver disease
  • History or evidence of renal disease; patients with history of nephrolithiasis will be allowed
  • Uncontrolled Type 1 or 2 diabetes
  • History or evidence of chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease History of any neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin (e.g. basal or squamous cell carcinoma)
  • Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of the first dose of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1000 mg 24 weeks
Drug: RO5024048
1500 mg po bid, 24 or 26 weeks
Drug: RO5024048
1000 mg po bid, 24 or 26 weeks
Drug: danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
Drug: ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
Active Comparator: 1000 mg 26 weeks
Drug: RO5024048
1500 mg po bid, 24 or 26 weeks
Drug: RO5024048
1000 mg po bid, 24 or 26 weeks
Drug: danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
Drug: ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
Drug: ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Experimental: 1500 mg 24 weeks
Drug: RO5024048
1500 mg po bid, 24 or 26 weeks
Drug: RO5024048
1000 mg po bid, 24 or 26 weeks
Drug: danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
Drug: ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
Drug: ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Experimental: 1500 mg 26 weeks
Drug: RO5024048
1500 mg po bid, 24 or 26 weeks
Drug: RO5024048
1000 mg po bid, 24 or 26 weeks
Drug: danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
Drug: ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
Drug: ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12)
Time Frame: approximately 2 years
approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: approximately 2 years
approximately 2 years
Sustained virologic response 4 weeks after treatment (SVR-4)
Time Frame: approximately 2 years
approximately 2 years
Sustained virologic response 24 weeks after treatment (SVR-24)
Time Frame: approximately 2 years
approximately 2 years
Change in serum HCV RNA levels
Time Frame: from baseline to Week 12
from baseline to Week 12
Virologic response over time
Time Frame: from baseline to 24 weeks after treatment
from baseline to 24 weeks after treatment
Correlation between trough concentrations of RO4995855 and virologic response
Time Frame: approximately 2 years
approximately 2 years
Incidence of direct-acting antiviral (DAA) resistance, including re-emergence of protease inhibitor resistant virus
Time Frame: approximately 2 years
approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NV22877
  • 2010-022659-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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