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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903954
• Other study ID #: NP28302
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2013
• Last updated: November 1, 2016
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
• placebo
Orally b.i.d.
• ribavirin [Copegus]
1000 mg or 1200 mg orally daily
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24		24 weeks	No
Secondary	Proportion of treatment-naïve patients eligible to stop all treatment at Week 28		28 weeks	No
Secondary	Safety: Incidence of adverse events		up to approximately 72 weeks	No