Clinical trial NCT01749150: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 1.5 years
measure: Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
timeFrame: up to 14 days
measure: Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System
timeFrame: from baseline to Week 36/48
measure: Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study
timeFrame: approximately 1.5 years
Secondary outcomes:
measure: Incidence of viral resistance to danoprevir
timeFrame: approximately 1.5 years
measure: Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4
timeFrame: approximately 1.5 years
measure: Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12
timeFrame: approximately 1.5 years
measure: 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
timeFrame: approximately 1.5 years
measure: 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
timeFrame: approximately 1.5 years
measure: SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12
timeFrame: approximately 1.5 years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Chiayi County
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Yunlin County
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: