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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01749150

First received: December 11, 2012

Last updated: November 1, 2016

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2012

Last Updated Date

November 1, 2016

Start Date ^ICMJE

April 2013

Primary Completion Date

February 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: Incidence of adverse events [ Time Frame: approximately 1.5 years ]
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir [ Time Frame: up to 14 days ]
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System [ Time Frame: from baseline to Week 36/48 ]
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study [ Time Frame: approximately 1.5 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01749150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of viral resistance to danoprevir [ Time Frame: approximately 1.5 years ]
Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4 [ Time Frame: approximately 1.5 years ]
Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: approximately 1.5 years ]
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12 [ Time Frame: approximately 1.5 years ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Drug: danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
Drug: danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 12 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
Drug: ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 12 weeks
Drug: ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 24 weeks

Study Arms

Experimental: with cirrhosis
Interventions:
- Drug: danoprevir + ritonavir
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: ribavirin [Copegus]
Experimental: without cirrhosis
Interventions:
- Drug: danoprevir + ritonavir
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: ribavirin [Copegus]

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2015

Primary Completion Date

February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of, Taiwan, Thailand

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01749150

Other Study ID Numbers ^ICMJE

YV28218

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

PRS Account

Hoffmann-La Roche

Verification Date

November 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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