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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

November 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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