A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive 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:	NCT00869661

Purpose

This 5 arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4.The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks.After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. 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: RO5024048 Drug: Pegasys Drug: 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-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection

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 virologic response [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virologic response (HCV RNA <15 IU/mL;HCV RNA <50 IU/mL) [ Time Frame: Weeks 4, 12, 24, 48 and 60 ] [ Designated as safety issue: No ]
Virologic response (HCV RNA <15 IU/mL) [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
SAEs, AEs leading to discontinuation; laboratory parameters [ Time Frame: At clinic visits, throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011

Arms	Assigned Interventions
1: Experimental	Drug: RO5024048 500mg bid for 12 weeks Drug: Pegasys 180 micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000/1200mg po daily for 24 or 48 weeks
2: Experimental	Drug: RO5024048 1000mg bid for 8 weeks Drug: Pegasys 180 micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000/1200mg po daily for 24 or 48 weeks
3: Experimental	Drug: RO5024048 1000mg bid for 12 weeks Drug: Pegasys 180 micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000/1200mg po daily for 24 or 48 weeks
4: Experimental	Drug: RO5024048 1000mg bid for 12 weeks Drug: Pegasys 180 micrograms sc weekly for 48 weeks Drug: Copegus 1000/1200mg po daily for 48 weeks
5: Active Comparator	Drug: Pegasys 180 micrograms sc weekly for 48 weeks Drug: Copegus 1000/1200mg po daily for 48 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 or 4;
treatment-naive.

Exclusion Criteria:

no previous treatment with any interferon- or ribavirin-based therapy;
other forms of liver disease;
HIV infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869661

Show 66 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:	NCT00869661 History of Changes
Other Study ID Numbers:	NV20536, 2008-008258-21
Study First Received:	March 25, 2009
Last Updated:	July 15, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections

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

ClinicalTrials.gov processed this record on September 01, 2010