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A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in 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: RO5024048 (Drug); Ribavirin [Copegus] (Drug); peginterferon alfa-2a [Pegasys] (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 equally randomized (1: 1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

Clinical Details

Official title: A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys« and Copegus« in Treatment-Na´ve Patients With Chronic Hepatitis C Genotype 1 or 4

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 (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)

Secondary outcome:

Virologic response over time

Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin

Resistance profile of RO5024048

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, 18-70 years of age

- hepatitis C, genotype 1 or 4, of over 6 months duration

- treatment-naïve

- negative pregnancy test; female patients of childbearing age and male patients with

female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin Exclusion Criteria:

- pregnant or breast feeding females or male partners of pregnant females

- previous interferon or ribavirin based therapy or investigational anti-HCV agent

- systemic antiviral therapy with established or perceived activity against HCV months prior to first dose of study drug

- hepatitis A or B, or HIV infection

- history or evidence of medical condition associated with chronic liver disease other

than HCV

Locations and Contacts

Calgary, Alberta T2N 4Z6, Canada

Vancouver, British Columbia V5Z 1H2, Canada

Vancouver, British Columbia V6Z 2K5, Canada

La Jolla, California 92037-1030, United States

Bradenton, Florida 34209, United States

Atlanta, Georgia 30309, United States

Honolulu, Hawaii 96813, United States

Honolulu, Hawaii 96817, United States

Chicago, Illinois 60637, United States

Indianapolis, Indiana 46202, United States

Kansas City, Kansas 66160, United States

Winnipeg, Manitoba R3A 1R9, Canada

Kansas City, Missouri 64131, United States

Lebanon, New Hampshire 03756, United States

Albuquerque, New Mexico 87131, United States

Bronx, New York 10468, United States

New York, New York 10003, United States

New York, New York 10021, United States

London, Ontario N6A 5A5, Canada

Ottawa, Ontario K1H 8L6, Canada

Philadelphia, Pennsylvania 19104, United States

Columbia, South Carolina 29204, United States

Nashville, Tennessee 37232, United States

Houston, Texas 77030, United States

San Antonio, Texas 78234, United States

Additional Information

Starting date: February 2010
Last updated: August 17, 2015

Page last updated: August 23, 2015

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