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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749150
• Other study ID #: YV28218
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2012
• Last updated: November 1, 2016
• Start date: April 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: TFDA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 1.5 years	No
Primary	Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir		up to 14 days	No
Primary	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	No
Primary	Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study		approximately 1.5 years	No
Secondary	Incidence of viral resistance to danoprevir		approximately 1.5 years	No
Secondary	Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4		approximately 1.5 years	No
Secondary	Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12		approximately 1.5 years	No
Secondary	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	No
Secondary	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	No
Secondary	SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12		approximately 1.5 years	No