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: April 7, 2014
Last verified: April 2014
  Purpose

This 6-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. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed tr! eatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: RO5024048
Drug: Pegasys
Drug: Copegus
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: 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
Experimental: 2 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
Experimental: 3 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
Experimental: 4 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
Active Comparator: 5 Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1000/1200mg po daily for 48 weeks
Experimental: 6 Drug: RO5024048
1000mg bid for 24 weeks
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
ClinicalTrials.gov Identifier: NCT00869661     History of Changes
Other Study ID Numbers: NV20536, 2008-008258-21
Study First Received: March 25, 2009
Last Updated: April 7, 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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014