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A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483742
First received: November 30, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: danoprevir
Drug: ritonavir
Drug: RO5024048
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and 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: 48 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24 ] [ Designated as safety issue: No ]
  • Antiviral activity: HCV RNA levels assessed by Roche COBAS Taqman HCV Test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emergence of viral resistance: HCV RNA gene sequence variations [ Time Frame: From baseline to Week 48 ] [ Designated as safety issue: No ]
  • Virologic response: HCV RNA levels [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Treatment-naïve Drug: danoprevir
100 mg orally bid, 24 weeks
Drug: ritonavir
100 mg orally bid, 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
Drug: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
Experimental: 2 Prior null responders Drug: danoprevir
100 mg orally bid, 24 weeks
Drug: ritonavir
100 mg orally bid, 24 weeks
Drug: RO5024048
1000 mg orally bid, 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
Drug: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age inclusive
  • Chronic hepatitis C, genotype 1 or 4
  • Cohort 1: Treatment-naïve for hepatitis C
  • Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
  • Liver biopsy confirming cirrhosis
  • Compensated cirrhosis (Child-Pugh A)

Exclusion Criteria:

  • Pregnant or lactating women or male partners of women who are pregnant
  • History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
  • Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
  • History of clinically significant cardiovascular or cerebrovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483742

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Anaheim, California, United States, 92801
Coronado, California, United States, 92118
La Jolla, California, United States, 92037
Long Beach, California, United States, 90807
United States, Florida
Deland, Florida, United States, 32720
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta, Georgia, United States, 30342
Atlanta, Georgia, United States, 30309
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
United States, New York
New York, New York, United States, 10021
United States, Texas
San Antonio, Texas, United States, 78215
Australia
Fitzroy, Australia, 3065
Melbourne, Australia, 3124
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
France
Montpellier, France, 34094
New Zealand
Auckland, New Zealand, 1142
Christchurch, New Zealand, 8140
Poland
Chorzów, Poland, 41-500
Myslowice, Poland, 41-400
Warszawa, Poland, 02-507
Wrocaw, Poland, 51-149
Slovakia
Bratislava, Slovakia, 389 591
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: NCT01483742     History of Changes
Other Study ID Numbers: NP27946, 2011-004129-28
Study First Received: November 30, 2011
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Fibrosis
Hepatitis C, Chronic
Liver Cirrhosis
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
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 19, 2013