A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection. - Full Text View

Purpose

This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: RO5024048 Drug: PEGASYS Drug: Copegus	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1

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:

AEs and laboratory parameters. [ Time Frame: Week 4, 8 and Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma concentration of HCV polymerase inhibitor [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
Antiviral activity [ Time Frame: Week 4, 8 and Week 72 ] [ Designated as safety issue: No ]

Enrollment:	107
Study Start Date:	September 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RO5024048 1500mg po bid for 4 weeks Drug: PEGASYS 180 micrograms sc weekly for 4 weeks
Experimental: 2	Drug: RO5024048 3000mg po bid for 4 weeks Drug: PEGASYS 180 micrograms sc weekly for 4 weeks
Experimental: 3	Drug: RO5024048 1500mg po bid for 4 weeks Drug: PEGASYS 180 micrograms sc weekly for 4 weeks Drug: Copegus 1000/1200mg po daily for 4 weeks
Active Comparator: 4	Drug: PEGASYS 180 micrograms sc weekly for 4 weeks Drug: Copegus 1000/1200mg po daily for 4 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;
CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
chronic liver disease consistent with CHC.

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: NCT00377182

Locations

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
United States, Florida

Gainesville, Florida, United States, 32610-0214

Sarasota, Florida, United States, 34243
United States, Illinois

Chicago, Illinois, United States, 60637
United States, Michigan

Novi, Michigan, United States, 48377
United States, New York

Manhasset, New York, United States, 11030

New York, New York, United States, 10029
United States, North Carolina

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

Dallas, Texas, United States, 75203

San Antonio, Texas, United States, 78234
United States, Virginia

Richmond, Virginia, United States, 23249
Puerto Rico

Santurce, Puerto Rico, 00909

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:	NCT00377182 History of Changes
Other Study ID Numbers:	PV18369
Study First Received:	September 15, 2006
Last Updated:	September 18, 2012
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013