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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Copegus (Drug); Copegus (Drug); Pegasys (Drug); Pegasys (Drug); RO5024048 (Drug); danoprevir (Drug); ritonavir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort 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 groups 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 receive 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 twice 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 receive another 24 weeks of Pegasys plus Copegus treatment.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment

Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment

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

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

Secondary outcome:

Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus

Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus

Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus

Virological response over time

Change in danoprevir plasma concentration

Change in RO5024048 plasma concentration

Hepatitis C virus drug resistance profile

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Wien 1090, Austria

La Tronche 38700, France

Paris 75651, France

Paris 75679, France

Pessac 33604, France

Vandoeuvre-les-nancy 54511, France

Berlin 13353, Germany

Essen 45122, Germany

Kiel 24105, Germany

Tübingen 72076, Germany

Guadalajara 44650, Mexico

Guadalajara 44280, Mexico

Bydgoszcz 85-030, Poland

Czeladz 41-250, Poland

Kielce 25-317, Poland

Warszawa 01-201, Poland

Łodz 91-347, Poland

San Juan 00927, Puerto Rico

Barcelona 08003, Spain

Madrid 28034, Spain

Madrid 28222, Spain

Sevilla 41014, Spain

Birmingham B15 2TH, United Kingdom

Dundee DD1 9SY, United Kingdom

London E1 1BB, United Kingdom

London W2 1PG, United Kingdom

Manchester M8 5RB, United Kingdom

Calgary, Alberta T2N 4Z6, Canada

Edmonton, Alberta T6G 2B7, Canada

Badalona, Barcelona 08915, Spain

Vancouver, British Columbia V5Z 1H2, Canada

Vancouver, British Columbia V5Z 1M9, Canada

Vancouver, British Columbia V6Z 2K5, Canada

La Jolla, California 92037-1030, United States

Long Beach, California 90822, United States

Sacramento, California 95817, United States

San Diego, California 92103, United States

Napoli, Campania 80135, Italy

Aurora, Colorado 80045, United States

Orlando, Florida 32804, United States

Decatur, Georgia 30033, United States

Chicago, Illinois 60637, United States

Milano, Lombardia 20162, Italy

Pavia, Lombardia 27100, Italy

New Orleans, Louisiana 70112, United States

Detroit, Michigan 48202-2689, United States

Darlinghurst, New South Wales 2010, Australia

Kingswood, New South Wales 2747, Australia

Westmead, New South Wales 2145, Australia

Manhasset, New York 11030, United States

New York, New York 10021, United States

Chapel Hill, North Carolina 27599-7584, United States

London, Ontario N6A 5A5, Canada

Ottawa, Ontario K1H 8L6, Canada

Toronto, Ontario M5G 1L7, Canada

Medford, Oregon 97504, United States

Porto Alegre, RS 90035-003, Brazil

Providence, Rhode Island 02905, United States

Ribeirao Preto, SP 14049-900, Brazil

Adelaide, South Australia 5000, Australia

Nashville, Tennessee 37211, United States

Houston, Texas 77030, United States

San Antonio, Texas 78215, United States

San Antonio, Texas 78234, United States

Pisa, Toscana 56124, Italy

Melbourne, Victoria 3004, Australia

Melbourne, Victoria 3186, Australia

Additional Information

Starting date: May 2011
Last updated: August 17, 2015

Page last updated: August 23, 2015

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