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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01903954
First received: July 17, 2013
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis C, Chronic Drug: peginterferon alfa-2a [Pegasys] Drug: placebo Drug: ribavirin [Copegus] Drug: setrobuvir Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24 [ Time Frame: 24 weeks ]
  • Proportion of treatment-naïve patients eligible to stop all treatment at Week 28 [ Time Frame: 28 weeks ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 72 weeks ]

Enrollment: 283
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator
Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Drug: placebo
Orally b.i.d.
Drug: ribavirin [Copegus]
1000 mg or 1200 mg orally daily
Experimental: Setrobuvir
Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Drug: ribavirin [Copegus]
1000 mg or 1200 mg orally daily
Drug: setrobuvir
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 Name: ANA598

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903954

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01903954     History of Changes
Obsolete Identifiers: NCT01281423
Other Study ID Numbers: NP28302
Study First Received: July 17, 2013
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017