Trial record 1 of 1 for:    NCT01057667
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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: August 26, 2014
Last verified: August 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: RO5024048
Drug: Ribavirin [Copegus]
Drug: peginterferon alfa-2a [Pegasys]
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: RO5024048
1000mg bid po, 24 weeks
Drug: Ribavirin [Copegus]
1000mg or 1200mg po daily
Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Active Comparator: B Drug: Ribavirin [Copegus]
1000mg or 1200mg po daily
Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly

  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

  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92037-1030
United States, Florida
Bradenton, Florida, United States, 34209
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Hawaii
Honolulu, Hawaii, United States, 96813
Honolulu, Hawaii, United States, 96817
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Missouri
Kansas City, Missouri, United States, 64131
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Bronx, New York, United States, 10468
New York, New York, United States, 10021
New York, New York, United States, 10003
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Columbia, South Carolina, United States, 29204
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78234
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Ottawa, Ontario, Canada, K1H 8L6
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: August 26, 2014
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
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014