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NCT Number: NCT01482403

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copegus

Drug

total daily dose of 1000 mg or 1200 mg for 24 weeks

Pegasys

Drug

180 microgram subcutaneous once a week for 24 weeks

boceprevir

Drug

800 mg three times a day for 24 weeks

mericitabine

Drug

1000 mg twice daily for 24 weeks

mericitabine placebo

Drug

mericitabine placebo

boceprevir placebo

Drug

boceprevir placebo

Primary outcomes

  1. Sustained virological response 12 weeks after treatment (SVR-12)

    Time frame: up to 60 weeks

Secondary outcomes

  1. Sustained virological response 4 weeks after treatment

    Time frame: up to 52 weeks

  2. Virologic response over time

    Time frame: 60 weeks

  3. Proportion of patients who develop treatment resistance

    Time frame: 60 weeks

  4. Safety (incidence of adverse events)

    Time frame: 60 weeks

  5. Pharmacokinetics: trough concentration of RO4995855

    Time frame: Day 1 and Week 8

  6. Pharmacokinetics: trough concentration of RO5012433

    Time frame: Day 1 and Week 8

  7. Pharmacokinetics: trough concentration of boceprevir

    Time frame: Day 1 and Week 8

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2011
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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