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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01482390
First received: November 28, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Drug: mericitabine
Drug: Placebo
Drug: Pegasys
Drug: Copegus
Drug: telaprevir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 TELAPREVIR AND PEGASYS®/COPEGUS® IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response 12 weeks after treatment (SVR-12) [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained virological response 4 weeks after treatment (SVR-4) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Virologic response over time [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who develop treatment resistance [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough concentration of RO4995855 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough concentration of RO5012433 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough concentration of telaprevir [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B Drug: mericitabine
1000 mg twice daily for 24 weeks
Drug: Pegasys
180 microgram subcutaneous once weekly for 48 weeks
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: telaprevir
750 mg three times daily for 12 weeks
Experimental: C Drug: mericitabine
1000 mg twice daily for 12 weeks
Drug: Placebo
Placebo to RO5024048 for 12 weeks (weeks 12-24)
Drug: Pegasys
180 microgram subcutaneous once weekly for 48 weeks
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: telaprevir
750 mg three times daily for 12 weeks
Experimental: A Drug: mericitabine
1000 mg twice daily for 24 weeks
Drug: Pegasys
180 microgram subcutaneous once weekly for 24 weeks
Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Drug: telaprevir
750 mg three times daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Patients 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482390

  Show 39 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01482390     History of Changes
Other Study ID Numbers: NV27779, 2011-002715-28
Study First Received: November 28, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014