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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 is currently recruiting participants.
Verified by Hoffmann-La Roche, April 2009
First Received: March 25, 2009   Last Updated: April 15, 2009   History of Changes
Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00869661
  Purpose

This 5 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. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: RO5024048
Drug: Pegasys
Drug: Copegus
Phase II

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virologic response [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virologic response (HCV RNA <15 IU/mL;HCV RNA <50 IU/mL) [ Time Frame: Weeks 4, 12, 24, 48 and 60 ] [ Designated as safety issue: No ]
  • Virologic response (HCV RNA <15 IU/mL) [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
  • SAEs, AEs leading to discontinuation; laboratory parameters [ Time Frame: At clinic visits, throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Estimated Study Completion Date: July 2011
Arms Assigned Interventions
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Experimental 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
5: Active Comparator 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

Contacts
Contact: Please reference Study ID Number: NV20536 973-235-5000
Contact: or 800-526-6367 (FOR US ONLY)

  Show 68 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers: NV20536, 2008-008258-21
Study First Received: March 25, 2009
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00869661     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Liver Diseases
Hepatitis, Chronic
Ribavirin
Hepatitis, Viral, Human
Antiviral Agents
Hepatitis
Virus Diseases
Signs and Symptoms
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Hepatitis, Viral, Human
Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Peginterferon alfa-2a
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009