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

NCT01903954 | Completed Phase 2

• 1 other identifier: NP28302
• Study Type: interventional
• Target: 283
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

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

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

Secondary Outcomes (3)

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

  24 weeks

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

  28 weeks

• Safety: Incidence of adverse events

  up to approximately 72 weeks

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)

Drug: peginterferon alfa-2a [Pegasys]; Drug: placebo; Drug: ribavirin [Copegus]

Setrobuvir

EXPERIMENTAL

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]; Drug: ribavirin [Copegus]; Drug: setrobuvir

Interventions

peginterferon alfa-2a [Pegasys] DRUG

180 mcg sc weekly

Active Comparator; Setrobuvir

placebo DRUG

Orally b.i.d.

Active Comparator

ribavirin [Copegus] DRUG

1000 mg or 1200 mg orally daily

Active Comparator; Setrobuvir

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

Also known as: ANA598

Setrobuvir

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin; setrobuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 19, 2013
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11