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: HCV polymerase inhibitor pro-drug Drug: Pegasys Drug: Copegus	Phase II

MedlinePlus related topics:

Hepatitis Hepatitis C

ChemIDplus related topics:

Ribavirin Peginterferon Alfa-2a Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	490
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2009

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

Show 63 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV19865
First Received:	August 16, 2007
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00517439
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Ribavirin

Peginterferon alfa-2a

Hepatitis, Viral, Human

Hepatitis C

Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00517439