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. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: RO4588161 Drug: Pegasys Drug: Copegus	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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-naïve Patients With Chronic he

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 (SVR) [ Time Frame: 24 weeks post treatment end (ie weeks 48 or 72) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virological response over time [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
SVR [ Time Frame: 12 weeks post treatment end (ie weeks 36 or 60) ] [ Designated as safety issue: No ]
Relapse rate [ Time Frame: End of treatment (ie weeks 24 or 48) ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout treatment ] [ Designated as safety issue: No ]

Enrollment:	516
Study Start Date:	December 2007
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RO4588161 1000mg po bid for 24 weeks Drug: Pegasys 180 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks
Experimental: 2	Drug: RO4588161 500mg po bid for 24 weeks Drug: Pegasys 180 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks
Experimental: 3	Drug: RO4588161 500mg po bid for 24 weeks Drug: Pegasys 180 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks
Experimental: 4	Drug: RO4588161 1500mg po bid for 24 weeks Drug: Pegasys 90 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks
Experimental: 5	Drug: RO4588161 1000mg po bid for 24 weeks Drug: Pegasys 90 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks
Experimental: 6	Drug: RO4588161 500mg po bid for 24 weeks Drug: Pegasys 90 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks
Active Comparator: 7	Drug: Pegasys 180 micrograms sc weekly for 24 weeks Drug: Copegus 1000/1200mg po daily for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517439

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Locations

United States, Arizona

Phoenix, Arizona, United States, 85054
United States, California

La Jolla, California, United States, 92037-1030

Long Beach, California, United States, 90822

Sacramento, California, United States, 95817

San Diego, California, United States, 92154

San Diego, California, United States, 92103-8465

San Francisco, California, United States, 94115
United States, Colorado

Aurora, Colorado, United States, 80045

Englewood, Colorado, United States, 80110
United States, Florida

Bradenton, Florida, United States, 34209

Gainesville, Florida, United States, 32610-0214

Miami, Florida, United States, 33136-1051
United States, Illinois

Chicago, Illinois, United States, 60637
United States, Maryland

Baltimore, Maryland, United States, 21287
United States, Minnesota

Plymouth, Minnesota, United States, 55446
United States, New York

Bronx, New York, United States, 10468

Manhasset, New York, United States, 11030

New York, New York, United States, 10021
United States, North Carolina

Chapel Hill, North Carolina, United States, 27599-7584
United States, Ohio

Cincinnati, Ohio, United States, 45267-0595
United States, Oregon

Portland, Oregon, United States, 97239
United States, Pennsylvania

Hershey, Pennsylvania, United States, 17033
United States, Rhode Island

Providence, Rhode Island, United States, 02905
United States, Tennessee

Nashville, Tennessee, United States, 37211
United States, Texas

Dallas, Texas, United States, 75203

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

San Antonio, Texas, United States, 78215
United States, Utah

Salt Lake City, Utah, United States, 84121
United States, Virginia

Fairfax, Virginia, United States, 22031

Richmond, Virginia, United States, 23249
Australia

Adelaide, Australia, 5000

Brisbane, Australia, 4120

Melbourne, Australia, 3004

Sydney, Australia, 2050

Sydney, Australia, 2145
Austria

Wien, Austria, 1090
Canada, Alberta

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

Vancouver, British Columbia, Canada, V5Z 1H2

Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario

Ottawa, Ontario, Canada, K1H 8L6

Toronto, Ontario, Canada, M5G 1L7
France

Clichy, France, 92118

Creteil, France, 94010

Marseille, France, 13285

Paris, France, 75014

Paris, France, 75651

Pessac, France, 33604

Vandoeuvre-les-nancy, France, 54511
Germany

Berlin, Germany, 13353

Frankfurt Am Main, Germany, 60590

Freiburg, Germany, 79106

Hamburg, Germany, 20251

Hannover, Germany, 30625

Koeln, Germany, 50924
Italy

Bologna, Italy, 40138

Napoli, Italy, 80131

Torino, Italy, 10126
Puerto Rico

Santurce, Puerto Rico, 00909
Spain

Badalona, Spain, 08915

Barcelona, Spain, 08003

Madrid, Spain, 28222

Sevilla, Spain, 41014

Valencia, Spain, 46014

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodríguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00517439 History of Changes
Other Study ID Numbers:	NV19865
Study First Received:	August 16, 2007
Last Updated:	May 23, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013