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NCT Number: NCT01903954

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

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending on response. Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, 18 to 65 years of age inclusive
  • Documented chronic hepatitis C
  • Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
  • Serum HCV RNA >/= 50,000 IU/mL at screening
  • HCV antibody positive at screening
  • HCV genotype 1
  • Body mass index (BMI) 18-38 kg/m2
  • In good health other than chronic HCV infection in the judgment of the principal investigators
  • Negative for hepatitis B and HIV infection

Exclusion criteria

  • Pregnant or breastfeeding women
  • For treatment-naïve patients: any previous treatment for HCV infection
  • For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
  • Co-infection with HIV or hepatitis C virus (HBV)
  • History or evidence of decompensated liver disease
  • History or evidence of hepatocellular carcinoma
  • History of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
  • Poorly controlled diabetes mellitus
  • One or more additional known primary causes of liver disease other than hepatitis C
  • History of acute or chronic pancreatitis
  • Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 mcg sc weekly

Placebo

Drug

Orally b.i.d.

ribavirin [Copegus]

Drug

1000 mg or 1200 mg orally daily

setrobuvir

Drug

Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks

Other names: ANA598

Primary outcomes

  1. Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs

    Time frame: 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)

Secondary outcomes

  1. Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24

    Time frame: 24 weeks

  2. Proportion of treatment-naïve patients eligible to stop all treatment at Week 28

    Time frame: 28 weeks

  3. Safety: Incidence of adverse events

    Time frame: up to approximately 72 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 19, 2013
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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