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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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
danoprevir + ritonavir
danoprevir + ritonavir
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
ribavirin [Copegus]
ribavirin [Copegus]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

with cirrhosis

without cirrhosis

Arm Description

Outcomes

Primary Outcome Measures

Safety: Incidence of adverse events
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2012
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01749150
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with cirrhosis
Arm Type
Experimental
Arm Title
without cirrhosis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
danoprevir + ritonavir
Intervention Description
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
Intervention Type
Drug
Intervention Name(s)
danoprevir + ritonavir
Intervention Description
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly, 12 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly, 24 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin [Copegus]
Intervention Description
1000-1200 mg orally daily in divided doses, 12 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin [Copegus]
Intervention Description
1000-1200 mg orally daily in divided doses, 24 weeks
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
approximately 1.5 years
Title
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
Time Frame
up to 14 days
Title
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
Title
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study
Time Frame
approximately 1.5 years
Secondary Outcome Measure Information:
Title
Incidence of viral resistance to danoprevir
Time Frame
approximately 1.5 years
Title
Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4
Time Frame
approximately 1.5 years
Title
Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12
Time Frame
approximately 1.5 years
Title
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
Title
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
Title
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12
Time Frame
approximately 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Chiayi County
ZIP/Postal Code
61363
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Yunlin County
ZIP/Postal Code
640
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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