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NCT Number: NCT01278134

A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

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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

Clichy, France

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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 patient, >/= 18 years of age
  • Chronic Hepatitis C of >/= 6 months duration at screening
  • HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
  • Naïve for treatment with interferon (pegylated or non-pegylated)
  • Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
  • Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception

Exclusion criteria

  • Pregnant or lactating women and males with female partners who are pregnant or lactating
  • Decompensated liver disease or impaired liver function
  • Cirrhosis or incomplete/transition to cirrhosis
  • Non-hepatitis C chronic liver disease
  • Hepatitis B or HIV infection
  • History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
  • History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
  • History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted

Treatment and study plan

Copegus placebo

Drug

1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks

RO5024048

Drug

1000 mg bid orally, up to 24 weeks

Danoprevir

Drug

100 mg bid orally, up to 24 weeks

peginterferon alfa-2a [Pegasys]

Drug

180 mcg sc weekly, 24 weeks

ribavirin [Copegus]

Drug

1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks

Ritonavir

Drug

100 mg bid orally, up to 24 weeks

Primary outcomes

  1. Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test

    Time frame: 24 weeks after end of treatment

  2. Safety: Incidence of adverse events

    Time frame: 1.5 years

Secondary outcomes

  1. Virological response (HCV RNA measured by Roche COBAS Taqman HCV test)

    Time frame: up to 48 weeks

  2. Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Time frame: 1.5 years

  3. Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Time frame: 1.5 years

  4. Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin

    Time frame: up to 24 weeks

  5. Viral resistance: HCV RNA sequencing and phenotypic analyses

    Time frame: up to 48 weeks

  6. Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Time frame: 1.5 years

  7. Quality of life: SF-36 questionnaire, Fatigue Severity Scale

    Time frame: up to 36 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 17, 2011
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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