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NCT Number: NCT01749150

A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.

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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

Busan, South Korea

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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 of East Asian or Southeast Asian origin, >/= 18 years of age
  • Presence of chronic genotype 1 hepatitis C infection
  • Treatment-naïve

Exclusion criteria

  • History or presence of decompensated liver disease
  • Presence or history of non-hepatitis C chronic liver disease
  • Positive for hepatitis B or HIV infection

Treatment and study plan

danoprevir + ritonavir

Drug

125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks

peginterferon alfa-2a [Pegasys]

Drug

180 mcg sc weekly, 12 weeks

ribavirin [Copegus]

Drug

1000-1200 mg orally daily in divided doses, 12 weeks

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 1.5 years

  2. Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir

    Time frame: up to 14 days

  3. Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System

    Time frame: from baseline to Week 36/48

  4. Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study

    Time frame: approximately 1.5 years

Secondary outcomes

  1. Incidence of viral resistance to danoprevir

    Time frame: approximately 1.5 years

  2. Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4

    Time frame: approximately 1.5 years

  3. Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12

    Time frame: approximately 1.5 years

  4. Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration

    Time frame: approximately 1.5 years

  5. Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration

    Time frame: approximately 1.5 years

  6. SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12

    Time frame: approximately 1.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2012
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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