A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

August 3, 2016 updated by: Hoffmann-La Roche

A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Study Overview

Status

Status

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

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
    • Ontario
      • London, Ontario, Canada, N6A 5A5
  • France
      • Creteil, France, 94010
      • Nice, France, 06202
      • Rennes, France, 35033
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20099
      • Hannover, Germany, 30625
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Lombardia
      • Milano, Lombardia, Italy, 20121
    • Toscana
      • Firenze, Toscana, Italy, 50134
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
  • Spain
      • Pontevedra, Spain, 36071
      • Valencia, Spain, 46014
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
  • United States
    • Colorado
      • Littleton, Colorado, United States, 80120
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Missouri
      • Kansas City, Missouri, United States, 64128
    • Texas
      • San Antonio, Texas, United States, 78215
    • Virginia
      • Chesapeake, Virginia, United States, 23320-1706

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index <18 or >/=36
  • Hepatitis A, hepatitis B, or HIV infection
  • Herbal remedies </=1 month prior to 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
  • Allocation: Randomized
  • 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.
Experimental: Treatment Arm A
24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: Pegasys
180 microgram subcutaneous once a week for 24 weeks
Drug: Pegasys
180 microgram subcutaneous once a week for 48 weeks
Drug: boceprevir
800 mg three times a day for 24 weeks
Drug: boceprevir
800 mg three times a day for 48 weeks
Drug: mericitabine
1000 mg twice daily for 24 weeks
Drug: boceprevir
800 mg three times a day for 44 weeks
Experimental: Treatment Arm B
24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: Pegasys
180 microgram subcutaneous once a week for 24 weeks
Drug: Pegasys
180 microgram subcutaneous once a week for 48 weeks
Drug: boceprevir
800 mg three times a day for 24 weeks
Drug: boceprevir
800 mg three times a day for 48 weeks
Drug: mericitabine
1000 mg twice daily for 24 weeks
Drug: boceprevir
800 mg three times a day for 44 weeks
Active Comparator: Treatment Arm C (Control)
4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: Pegasys
180 microgram subcutaneous once a week for 24 weeks
Drug: Pegasys
180 microgram subcutaneous once a week for 48 weeks
Drug: boceprevir
800 mg three times a day for 24 weeks
Drug: boceprevir
800 mg three times a day for 48 weeks
Drug: boceprevir
800 mg three times a day for 44 weeks
Drug: mericitabine placebo
mericitabine placebo
Drug: boceprevir placebo
boceprevir placebo

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 virological response 12 weeks after treatment (SVR-12)
Time Frame: up to 60 weeks
up to 60 weeks

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: 60 weeks
60 weeks
Sustained virological response 4 weeks after treatment
Time Frame: up to 52 weeks
up to 52 weeks
Virologic response over time
Time Frame: 60 weeks
60 weeks
Proportion of patients who develop treatment resistance
Time Frame: 60 weeks
60 weeks
Pharmacokinetics: trough concentration of RO4995855
Time Frame: Day 1 and Week 8
Day 1 and Week 8
Pharmacokinetics: trough concentration of RO5012433
Time Frame: Day 1 and Week 8
Day 1 and Week 8
Pharmacokinetics: trough concentration of boceprevir
Time Frame: Day 1 and Week 8
Day 1 and Week 8

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 1, 2011

Primary Completion (Actual)

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.
January 1, 2014

Study Completion (Actual)

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.
January 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).
November 28, 2011

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.
November 28, 2011

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.
November 30, 2011

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.
August 5, 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.
August 3, 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.
August 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.
  • NV27780
  • 2011-002714-37 (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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