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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01749150
First received: December 11, 2012
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This Phase II, open-label, parallel-arm study will evaluate the safety, tolerabi lity, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in tre atment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patie nts will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet or ally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and C opegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 week s in patients without cirrhosis and 24 weeks in patients with compensated cirrho sis.


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:


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 ]

Enrollment: 61
Study Start Date: April 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749150

Locations
Korea, Republic of
Busan, Korea, Republic of, 614-735
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 110-744
Taiwan
Chiayi County, Taiwan, 61363
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 40447
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Yunlin County, Taiwan, 640
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10330
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: November 17, 2014
Health Authority: Taiwan: TFDA

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

ClinicalTrials.gov processed this record on November 20, 2014