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: October 20, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: Pegasys
Drug: Placebo
Drug: mericitabine
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: A Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Drug: Pegasys
180 microgram subcutaneous once weekly for 24 weeks
Drug: mericitabine
1000 mg twice daily for 24 weeks
Drug: telaprevir
750 mg three times daily for 12 weeks
Experimental: B Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: Pegasys
180 microgram subcutaneous once weekly for 48 weeks
Drug: mericitabine
1000 mg twice daily for 24 weeks
Drug: telaprevir
750 mg three times daily for 12 weeks
Experimental: C Drug: Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Drug: Pegasys
180 microgram subcutaneous once weekly for 48 weeks
Drug: Placebo
Placebo to RO5024048 for 12 weeks (weeks 12-24)
Drug: mericitabine
1000 mg twice daily for 12 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014