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A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.

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.
 
ClinicalTrials.gov Identifier: NCT00377182
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Copegus Drug: PEGASYS Drug: RO5024048 1500mg Drug: RO5024048 3000mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PEGASYS with COPEGUS Drug: Copegus
1000/1200mg po daily for 4 weeks

Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Experimental: RO5024048 1500mg in combination with PEGASYS Drug: PEGASYS
180 micrograms sc weekly for 4 weeks

Drug: RO5024048 1500mg
1500mg po bid for 4 weeks
Experimental: RO5024048 3000mg in combination with PEGASYS Drug: PEGASYS
180 micrograms sc weekly for 4 weeks

Drug: RO5024048 3000mg
3000mg po bid for 4 weeks
Experimental: RO5024048 in combination with PEGASYS and COPEGUS Drug: Copegus
1000/1200mg po daily for 4 weeks

Drug: PEGASYS
180 micrograms sc weekly for 4 weeks

Drug: RO5024048 1500mg
1500mg po bid for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) and laboratory parameters. [ Time Frame: Week 4, 8 and Week 72 ]

Secondary Outcome Measures :
  1. Plasma concentration of HCV polymerase inhibitor [ Time Frame: Week 4 and 8 ]
  2. Antiviral activity [ Time Frame: Week 4, 8 and Week 72 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
  • chronic liver disease consistent with CHC.

Exclusion Criteria:

  • infection with any HCV genotype other than genotype 1;
  • previous treatment for CHC;
  • medical condition associated with chronic liver disease other than CHC;
  • HIV, Hepatitis A, Hepatitis B infection.
Contacts and Locations
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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): NCT00377182


Locations
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United States, California
La Jolla, California, United States, 92037-1030
Long Beach, California, United States, 90822
Sacramento, California, United States, 95817
San Diego, California, United States, 92103-8465
San Diego, California, United States, 92154
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Bradenton, Florida, United States, 34209
Gainesville, Florida, United States, 32610-0214
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Michigan
Novi, Michigan, United States, 48377
United States, New York
Manhasset, New York, United States, 11030
New York, New York, United States, 10029
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7584
United States, Texas
Dallas, Texas, United States, 75203
Fort Sam Houston, Texas, United States, 78234-3879
United States, Virginia
Richmond, Virginia, United States, 23249
Puerto Rico
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377182    
Other Study ID Numbers: PV18369
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents