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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01057667

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 II

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 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:	165
Study Start Date:	February 2010
Estimated Study Completion Date:	September 2012

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

Show 25 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
ClinicalTrials.gov Identifier:	NCT01057667 History of Changes
Other Study ID Numbers:	NV22621
Study First Received:	January 26, 2010
Last Updated:	August 16, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis C
Hepatitis C, Chronic
Angiogenesis Inhibitors
Growth Inhibitors
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin

Peginterferon alfa-2a
Interferon Alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 01, 2010