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A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

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); Pegasys (Drug); Pegasys (Drug); RO4588161 (Drug); RO4588161 (Drug); RO4588161 (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 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive SOC for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Clinical Details

Official title: A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-na´ve Patients With Chronic he

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

Primary outcome: Sustained virological response (SVR)

Secondary outcome:

Virological response over time

SVR

Relapse rate

AEs, laboratory parameters.

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;

- chronic liver disease consistent with CHC;

- compensated liver disease.

Exclusion Criteria:

- infection with any HCV genotype other than genotype 1;

- previous treatment for CHC;

- medical condition associated with chronic liver disease other than CHC;

- HIV, hepatitis A, hepatitis B infection.

Locations and Contacts

Adelaide 5000, Australia

Greenslopes 4120, Australia

Melbourne 3004, Australia

Sydney 2050, Australia

Sydney 2145, Australia

Wien 1090, Austria

Clichy 92118, France

Creteil 94010, France

Marseille 13285, France

Paris 75014, France

Paris 75651, France

Pessac 33604, France

Vandoeuvre-les-nancy 54511, France

Berlin 13353, Germany

Frankfurt Am Main 60590, Germany

Freiburg 79106, Germany

Hamburg 20246, Germany

Hannover 30625, Germany

K├Âln 50937, Germany

Bologna 40138, Italy

Napoli 80131, Italy

Torino 10126, Italy

Santurce 00909, Puerto Rico

Badalona 08915, Spain

Barcelona 08003, Spain

Madrid 28222, Spain

Sevilla 41014, Spain

Valencia 46014, Spain

Calgary, Alberta T2N 4N1, Canada

Phoenix, Arizona 85054, United States

Vancouver, British Columbia V5Z 1H2, Canada

Vancouver, British Columbia V5Z 1M9, Canada

La Jolla, California 92037-1030, United States

Long Beach, California 90822, United States

Sacramento, California 95817, United States

San Diego, California 92103-8465, United States

San Diego, California 92154, United States

San Francisco, California 94115, United States

Aurora, Colorado 80045, United States

Englewood, Colorado 80110, United States

Bradenton, Florida 34209, United States

Gainesville, Florida 32610-0214, United States

Miami, Florida 33136-1051, United States

Chicago, Illinois 60637, United States

Baltimore, Maryland 21287, United States

Plymouth, Minnesota 55446, United States

Bronx, New York 10468, United States

Manhasset, New York 11030, United States

New York, New York 10021, United States

Chapel Hill, North Carolina 27599-7584, United States

Cincinnati, Ohio 45267-0595, United States

Ottawa, Ontario K1H 8L6, Canada

Toronto, Ontario M5G 1L7, Canada

Portland, Oregon 97239, United States

Hershey, Pennsylvania 17033, United States

Providence, Rhode Island 02905, United States

Nashville, Tennessee 37211, United States

Dallas, Texas 75203, United States

Fort Sam Houston, Texas 78234-3879, United States

San Antonio, Texas 78215, United States

Salt Lake City, Utah 84121, United States

Fairfax, Virginia 22031, United States

Richmond, Virginia 23249, United States

Additional Information

Starting date: December 2007
Last updated: August 17, 2015

Page last updated: August 23, 2015

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