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

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

Sponsors

Lead sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
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.

Overall Status Completed
Start Date April 2013
Completion Date February 2015
Primary Completion Date February 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
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
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12 approximately 1.5 years
Enrollment 61
Condition
Intervention

Intervention type: Drug

Intervention name: danoprevir + ritonavir

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

Arm group label: without cirrhosis

Intervention type: Drug

Intervention name: danoprevir + ritonavir

Description: 125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks

Arm group label: with cirrhosis

Intervention type: Drug

Intervention name: peginterferon alfa-2a [Pegasys]

Description: 180 mcg sc weekly, 12 weeks

Arm group label: without cirrhosis

Intervention type: Drug

Intervention name: peginterferon alfa-2a [Pegasys]

Description: 180 mcg sc weekly, 24 weeks

Arm group label: with cirrhosis

Intervention type: Drug

Intervention name: ribavirin [Copegus]

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

Arm group label: without cirrhosis

Intervention type: Drug

Intervention name: ribavirin [Copegus]

Description: 1000-1200 mg orally daily in divided doses, 24 weeks

Arm group label: with cirrhosis

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
facility
| Busan, 614-735, Korea, Republic of
| Seoul, 110-744, Korea, Republic of
| Seoul, 120-752, Korea, Republic of
| Seoul, 135-710, Korea, Republic of
| Chiayi County, 61363, Taiwan
| Kaohsiung, 807, Taiwan
| Taichung, 40447, Taiwan
| Taipei, 100, Taiwan
| Taoyuan, 333, Taiwan
| Yunlin County, 640, Taiwan
| Bangkok, 10330, Thailand
| Bangkok, 10700, Thailand
| Chiang Mai, 50200, Thailand
Location Countries

Korea, Republic of

Taiwan

Thailand

Verification Date

November 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: with cirrhosis

Arm group type: Experimental

Arm group label: without cirrhosis

Arm group type: Experimental

Study Design Info

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov