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A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

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); RO5024048 (Drug); RO5024048 (Drug); RO5024048 (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 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.

Clinical Details

Official title: A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys« and Ribavirin« (SOC) Versus SOC in Treatment-Na´ve Patients With HCV Genotype 1 or 4 Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level

Secondary outcome:

Virologic response: Percentage of patients with undetectable Hepatitis C RNA level

Virologic response: Percentage of patients with undetectable Hepatitis C RNA level

Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment

Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients, 18-65 years of age

- Chronic hepatitis C, genotype 1 or 4

- Treatment-naive

Exclusion Criteria:

- No previous treatment with any interferon- or ribavirin-based therapy

- Other forms of liver disease

- HIV infection

Locations and Contacts

Wien 1090, Austria

Creteil 94010, France

La Tronche 38700, France

Lille 59037, France

Nice 06202, France

Paris 75679, France

Paris 75651, France

Pessac 33604, France

Vandoeuvre-les-nancy 54511, France

Berlin 13353, Germany

Frankfurt Am Main 60590, Germany

Freiburg 79106, Germany

Hannover 30625, Germany

Muenchen 81377, Germany

Ulm 89081, Germany

Santurce 00909, Puerto Rico

Barcelona 08036, Spain

Barcelona 08003, Spain

Granada 18003, Spain

Madrid 28222, Spain

Sevilla 41014, Spain

Valencia 46014, Spain

London SE5 9RS, United Kingdom

London W1 1TF, United Kingdom

Birmingham, Alabama 35294, United States

Calgary, Alberta T2N 4Z6, Canada

Edmonton, Alberta T6G 2B7, Canada

Badalona, Barcelona 08915, Spain

Vancouver, British Columbia V5Z 1M9, Canada

Vancouver, British Columbia V6Z 2K5, Canada

La Jolla, California 92037-1030, United States

Sacramento, California 95817, United States

San Diego, California 92103-8465, United States

San Francisco, California 94115, United States

Washington, District of Columbia 20037, United States

Bologna, Emilia-Romagna 40138, Italy

Bradenton, Florida 34209, United States

Gainesville, Florida 32610-0214, United States

Marietta, Georgia 30060, United States

Chicago, Illinois 60637, United States

La Coruna, La Coru├▒a 15006, Spain

Milano, Lombardia 20121, Italy

Lutherville, Maryland 21093, United States

Kansas City, Missouri 64131, United States

Newark, New Jersey 07102, United States

Sydney, New South Wales 2050, Australia

New York, New York 10021, United States

London, Ontario N6A 5A5, Canada

Toronto, Ontario M5G 1L7, Canada

Hershey, Pennsylvania 17033, United States

Torino, Piemonte 10126, Italy

Montreal, Quebec H2X 3J4, Canada

Greenslopes, Queensland 4120, Australia

Herston, Queensland 4006, Australia

Woolloongabba, Queensland 4102, Australia

Providence, Rhode Island 02905, United States

Columbia, South Carolina 29204, United States

Nashville, Tennessee 37211, United States

Houston, Texas 77030, United States

San Antonio, Texas 78234, United States

Pisa, Toscana 56124, Italy

Fitzroy, Victoria 3065, Australia

Melbourne, Victoria 3004, Australia

Richmond, Virginia 23249, United States

Nedlands, Western Australia 6009, Australia

Perth, Western Australia 6001, Australia

Additional Information

Starting date: February 2001
Last updated: August 17, 2015

Page last updated: August 23, 2015

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