A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
NCT ID: NCT00545233
Last Updated: 2012-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
155 participants
INTERVENTIONAL
2008-01-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-INF alpha-2a + ribavirin+ pioglitazone
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
peginterferon alfa-2a [Pegasys]
180 micrograms subcutaneous weekly for 48 weeks
ribavirin [Copegus]
1000-1600 mg day orally for 48 weeks.
Pioglitazone
30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
PEG-INF alpha-2a + ribavirin
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
peginterferon alfa-2a [Pegasys]
180 micrograms subcutaneous weekly for 48 weeks
ribavirin [Copegus]
1000-1600 mg day orally for 48 weeks.
Interventions
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peginterferon alfa-2a [Pegasys]
180 micrograms subcutaneous weekly for 48 weeks
ribavirin [Copegus]
1000-1600 mg day orally for 48 weeks.
Pioglitazone
30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* chronic hepatitis C, genotype 1;
* insulin resistance.
Exclusion Criteria
* cirrhosis;
* previous treatment for chronic hepatitis C;
* insulin treatment during prior 2 weeks;
* type 1 diabetes.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Anaheim, California, United States
Fresno, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Merced, California, United States
Palo Alto, California, United States
Pasadena, California, United States
San Clemente, California, United States
San Mateo, California, United States
Englewood, Colorado, United States
Littleton, Colorado, United States
Hartford, Connecticut, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Downers Grove, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Duluth, Minnesota, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Egg Harbour Township, New Jersey, United States
Hackensack, New Jersey, United States
Bayside, New York, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
West Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Sam Houston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Tacoma, Washington, United States
San Juan, , Puerto Rico
Countries
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Other Identifiers
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ML21301
Identifier Type: -
Identifier Source: org_study_id
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