A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

NCT01749150 | Completed Phase 2

• 1 other identifier: YV28218
• Study Type: interventional
• Target: 61
• Locations: 3 countries
• Sites: 13

Brief Summary

This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (4)

• Safety: Incidence of adverse events

  approximately 1.5 years

• Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir

  up to 14 days

• Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System

  from baseline to Week 36/48

• Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study

  approximately 1.5 years

Secondary Outcomes (6)

• Incidence of viral resistance to danoprevir

  approximately 1.5 years

• Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4

  approximately 1.5 years

• Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12

  approximately 1.5 years

• Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration

  approximately 1.5 years

• Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration

  approximately 1.5 years

Study Arms (2)

with cirrhosis

EXPERIMENTAL

Drug: danoprevir + ritonavir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

without cirrhosis

EXPERIMENTAL

Drug: danoprevir + ritonavir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

Interventions

danoprevir + ritonavir DRUG

125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks

without cirrhosis

peginterferon alfa-2a [Pegasys] DRUG

180 mcg sc weekly, 12 weeks

without cirrhosis

ribavirin [Copegus] DRUG

1000-1200 mg orally daily in divided doses, 12 weeks

without cirrhosis

Eligibility Criteria

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

You may qualify if:

• Adult patients of East Asian or Southeast Asian origin, \>/= 18 years of age
• Presence of chronic genotype 1 hepatitis C infection
• Treatment-naïve

You may not qualify if:

• History or presence of decompensated liver disease
• Presence or history of non-hepatitis C chronic liver disease
• Positive for hepatitis B or HIV infection

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (13)

Unknown Facility

Busan, 614-735, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Chiayi County, 61363, Taiwan

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Taichung, 40447, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

Unknown Facility

Yunlin County, 640, Taiwan

Location

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

danoprevir; Ritonavir; peginterferon alfa-2a; Ribavirin

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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 13, 2012
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

KR (4); TW (6); TH (3)