A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: RO5024048 Drug: peginterferon alfa-2a [Pegasys] Drug: Ribavirin [Copegus]	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test) [ Time Frame: 24 weeks after last treatment dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virologic response over time [ Time Frame: weeks 4, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
Resistance profile of RO5024048 [ Time Frame: weeks 1-24 ] [ Designated as safety issue: No ]

Enrollment:	168
Study Start Date:	February 2010
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: RO5024048 1000mg bid po, 24 weeks Drug: peginterferon alfa-2a [Pegasys] 180mcg sc weekly Drug: Ribavirin [Copegus] 1000mg or 1200mg po daily
Active Comparator: B	Drug: peginterferon alfa-2a [Pegasys] 180mcg sc weekly Drug: Ribavirin [Copegus] 1000mg or 1200mg po daily

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 </=3 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057667

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Locations

United States, California

La Jolla, California, United States, 92037-1030
United States, Florida

Bradenton, Florida, United States, 34209
United States, Georgia

Atlanta, Georgia, United States, 30309
United States, Hawaii

Honolulu, Hawaii, United States, 96813

Honolulu, Hawaii, United States, 96817
United States, Illinois

Chicago, Illinois, United States, 60637
United States, Indiana

Indianapolis, Indiana, United States, 46202
United States, Kansas

Kansas City, Kansas, United States, 66160
United States, Missouri

Kansas City, Missouri, United States, 64131
United States, New Hampshire

Lebanon, New Hampshire, United States, 03756
United States, New Mexico

Albuquerque, New Mexico, United States, 87131
United States, New York

Bronx, New York, United States, 10468

New York, New York, United States, 10021

New York, New York, United States, 10003
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina

Columbia, South Carolina, United States, 29204
United States, Tennessee

Nashville, Tennessee, United States, 37232
United States, Texas

Fort Sam Houston, Texas, United States, 78234-3879

Houston, Texas, United States, 77030
Canada, Alberta

Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia

Vancouver, British Columbia, Canada, V5Z 1H2

Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario

London, Ontario, Canada, N6A 5A5

Ottawa, Ontario, Canada, K1H 8L6

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:	NCT01057667 History of Changes
Other Study ID Numbers:	NV22621
Study First Received:	January 26, 2010
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013