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Completed

NCT Number: NCT01057667

A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

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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–70 year

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, 18-70 years of age
  • hepatitis C, genotype 1 or 4, of over 6 months duration
  • treatment-naïve
  • negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion criteria

  • pregnant or breast feeding females or male partners of pregnant females
  • previous interferon or ribavirin based therapy or investigational anti-HCV agent
  • systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
  • hepatitis A or B, or HIV infection
  • history or evidence of medical condition associated with chronic liver disease other than HCV

Treatment and study plan

RO5024048

Drug

1000mg bid po, 24 weeks

ribavirin [Copegus]

Drug

1000mg or 1200mg po daily

peginterferon alfa-2a [Pegasys]

Drug

180mcg sc weekly

Primary outcomes

  1. Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)

    Time frame: 24 weeks after last treatment dose

Secondary outcomes

  1. Virologic response over time

    Time frame: weeks 4, 12, 24, 36, 48 and 60

  2. Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin

    Time frame: week 12 and 24

  3. Resistance profile of RO5024048

    Time frame: weeks 1-24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2010
Registry last updated
Nov 2, 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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