A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive 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:
NCT00869661
First received: March 25, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in co mbination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chron ic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 5 00mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO502 4048 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 furt her 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 week s. Group 6 provides retreatment on an open-label basis for patients of Group 5 w ho failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Cope gus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study tr eatment is 6-12 months.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: Pegasys
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-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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virologic response: Percentage of patients with undetectable Hepatitis C RNA level [ Time Frame: 60 Weeks ] [ Designated as safety issue: No ]
  • Virologic response: Percentage of patients with undetectable Hepatitis C RNA level [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
  • Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 413
Study Start Date: February 2001
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Copegus
1000/1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Drug: RO5024048
500mg bid for 12 weeks
Experimental: 2 Drug: Copegus
1000/1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Drug: RO5024048
1000mg bid for 8 weeks
Experimental: 3 Drug: Copegus
1000/1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Drug: RO5024048
1000mg bid for 12 weeks
Experimental: 4 Drug: Copegus
1000/1200mg po daily for 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: RO5024048
1000mg bid for 12 weeks
Active Comparator: 5 Drug: Copegus
1000/1200mg po daily for 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Experimental: 6 Drug: Copegus
1000/1200mg po daily for 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: RO5024048
1000mg bid 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 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
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: NCT00869661

  Show 66 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: NCT00869661     History of Changes
Other Study ID Numbers: NV20536, 2008-008258-21
Study First Received: March 25, 2009
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae 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 22, 2014