A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01331850
First received: March 28, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, open-label, multi-center study will evaluate the sustained viro logical response, pharmacokinetics and safety of various combinations of danopre vir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chroni c hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohor t A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all gro ups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will recei ve Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg tw ice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will recei ve another 24 weeks of Pegasys plus Copegus treatment.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: Pegasys
Drug: RO5024048
Drug: danoprevir
Drug: ritonavir
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: A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Virological response over time [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in danoprevir plasma concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in RO5024048 plasma concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Hepatitis C virus drug resistance profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 381
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: 2 Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: 3 Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: 4 Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: 5 Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: 6 Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 48 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 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, age 18 years and older
  • Presence of hepatitis C infection, genotype 1a or 1b
  • Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

Exclusion Criteria:

  • Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
  • Patients with cirrhosis
  • Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
  • Co-infection with hepatitis B or human immunodeficiency virus (HIV)
  • History or evidence of chronic liver disease other than hepatitis C
  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: NCT01331850

  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92037-1030
Long Beach, California, United States, 90822
Sacramento, California, United States, 95817
San Diego, California, United States, 92103
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Orlando, Florida, United States, 32804
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, New York
Manhasset, New York, United States, 11030
New York, New York, United States, 10021
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7584
United States, Oregon
Medford, Oregon, United States, 97504
United States, Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
Nashville, Tennessee, United States, 37211
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78215
San Antonio, Texas, United States, 78234
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
Kingswood, New South Wales, Australia, 2747
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne, Victoria, Australia, 3004
Melbourne, Victoria, Australia, 3186
Austria
Wien, Austria, 1090
Brazil
Porto Alegre, RS, Brazil, 90035-003
Ribeirao Preto, SP, Brazil, 14049-900
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2K5
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 1L7
France
La Tronche, France, 38700
Paris, France, 75679
Paris, France, 75651
Pessac, France, 33604
Vandoeuvre-les-nancy, France, 54511
Germany
Berlin, Germany, 13353
Essen, Germany, 45122
Kiel, Germany, 24105
Tübingen, Germany, 72076
Italy
Napoli, Campania, Italy, 80135
Milano, Lombardia, Italy, 20162
Pavia, Lombardia, Italy, 27100
Pisa, Toscana, Italy, 56124
Mexico
Guadalajara, Mexico, 44650
Guadalajara, Mexico, 44280
Poland
Bydgoszcz, Poland, 85-030
Czeladz, Poland, 41-250
Kielce, Poland, 25-317
Lodz, Poland, 91-347
Warszawa, Poland, 01-201
Puerto Rico
San Juan, Puerto Rico, 00927
Spain
Badalona, Barcelona, Spain, 08915
Barcelona, Spain, 08003
Madrid, Spain, 28222
Madrid, Spain, 28034
Sevilla, Spain, 41014
United Kingdom
Birmingham, United Kingdom, B15 2TH
Dundee, United Kingdom, DD1 9SY
London, United Kingdom, W2 1PG
London, United Kingdom, E1 1BB
Manchester, United Kingdom, M8 5RB
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: NCT01331850     History of Changes
Other Study ID Numbers: WV21913, 2010-019585-90
Study First Received: March 28, 2011
Last Updated: August 26, 2014
Health Authority: Italy: Comitato Etico Azienda Ospedalier Pisana-Toscana

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

ClinicalTrials.gov processed this record on September 22, 2014