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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:
ClinicalTrials.gov Identifier:
NCT00869661
First Posted: March 26, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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 treatment. 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: Copegus Drug: Pegasys Drug: RO5024048 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Virologic response: Percentage of patients with undetectable Hepatitis C RNA level [ Time Frame: 60 Weeks ]
  • Virologic response: Percentage of patients with undetectable Hepatitis C RNA level [ Time Frame: 12 weeks post-treatment ]
  • 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 ]
  • Safety: Incidence of adverse events [ Time Frame: 72 weeks ]

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: Group 1
RO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
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: Group 2
RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
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: Group 3
RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
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: Group 4
Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks
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: Group 5
Group 5 will receive SOC for 48 weeks
Drug: Copegus
1000/1200mg po daily for 48 weeks
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Experimental: Group 6
Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks.
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869661


  Show 66 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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
First Submitted: March 25, 2009
First Posted: March 26, 2009
Last Update Posted: November 2, 2016
Last Verified: November 2016

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