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Completed

NCT Number: NCT01220947

A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

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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

Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults patients, >/=18 years of age
  • Chronic Hepatitis C, Genotype 1 and 4
  • HCV RNA >/=50,000 IU/mL
  • treatment-naive

Exclusion criteria

  • Patients with cirrhosis or incomplete/transition to cirrhosis
  • Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Treatment and study plan

Copegus

Drug

Copegus 1000 mg or 1200 mg po daily for 24 weeks.

Danoprevir

Drug

Danoprevir 50 mg BID

Pegasys

Drug

Pegasys 180 microgram sc qw

Ritonavir

Drug

Ritonavir 100 mg

Primary outcomes

  1. Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Time frame: 24 weeks after end of treatment

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: from baseline up to 72 weeks

  2. Evaluation of relapse rate

    Time frame: up to 24 weeks after end of treatment

  3. Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)

    Time frame: from baseline up to 72 weeks

  4. Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Time frame: From baseline up to 72 weeks

  5. Evaluation of virological breakthrough (viral load rebound) rate

    Time frame: up to 72 weeks

  6. Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)

    Time frame: up to 72 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 14, 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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