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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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01749150
First received: December 11, 2012
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: danoprevir + ritonavir
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of viral resistance to danoprevir [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4 [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12 [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12 [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: without cirrhosis Drug: danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 12 weeks
Drug: ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 12 weeks
Experimental: with cirrhosis 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, 24 weeks
Drug: ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749150

Contacts
Contact: Reference Study ID Number: YV28218 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Korea, Republic of
Recruiting
Busan, Korea, Republic of, 614-735
Recruiting
Seoul, Korea, Republic of, 110-744
Recruiting
Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 135-710
Taiwan
Not yet recruiting
Chiayi County, Taiwan, 61363
Recruiting
Kaohsiung, Taiwan, 807
Recruiting
Taichung, Taiwan, 40447
Not yet recruiting
Taipei, Taiwan, 100
Not yet recruiting
Taoyuan, Taiwan, 333
Not yet recruiting
Yunlin County, Taiwan, 640
Thailand
Recruiting
Bangkok, Thailand, 10700
Recruiting
Bangkok, Thailand, 10330
Recruiting
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01749150     History of Changes
Other Study ID Numbers: YV28218
Study First Received: December 11, 2012
Last Updated: May 23, 2013
Health Authority: Taiwan: TFDA

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Fibrosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
 Ribavirin
Ritonavir
Peginterferon alfa-2a
Interferon-alpha
Lactams
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013