Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01057667
First received: January 26, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterfe ron 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 twic e daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Cope gus (1000mg or 1200mg orally daily). Patients achieving a rapid virological resp onse (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 anoth er 24 weeks up to week 48. Patients in arm B will receive standard treatment wit h 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 sam ple size is <200.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: Ribavirin [Copegus]
Drug: RO5024048
Phase 2

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:


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: 168
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Drug: Ribavirin [Copegus]
1000mg or 1200mg po daily
Drug: RO5024048
1000mg bid po, 24 weeks
Active Comparator: B 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01057667     History of Changes
Other Study ID Numbers: NV22621
Study First Received: January 26, 2010
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014