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.
A Randomized, Open-label Study of the Effect of PEGASYS ® Plus COPEGUS® With or Without Concomitant Pioglitazone (Actos®) on Early Viral Kinetics in Treatment-naive Patients With Chronic Hepatitis C, Genotype-1, and Insulin Resistance
1 other identifier
interventional
155
2 countries
66
Brief Summary
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2008
Typical duration for phase_4
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
May 7, 2012
CompletedMay 7, 2012
April 1, 2012
2.9 years
October 16, 2007
February 8, 2012
April 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment
Secondary Outcomes (21)
Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy
Percentage of Participants Achieving Virologic Response
Weeks 4, 12, 24, 48, 60, 72
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72
Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)
Week 72
Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks
Up to 48 Weeks
- +16 more secondary outcomes
Study Arms (2)
PEG-INF alpha-2a + ribavirin+ pioglitazone
EXPERIMENTALParticipants 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.
PEG-INF alpha-2a + ribavirin
ACTIVE COMPARATORParticipants 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.
Interventions
180 micrograms subcutaneous weekly for 48 weeks
1000-1600 mg day orally for 48 weeks.
30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- chronic hepatitis C, genotype 1;
- insulin resistance.
You may not qualify if:
- other forms of liver disease;
- cirrhosis;
- previous treatment for chronic hepatitis C;
- insulin treatment during prior 2 weeks;
- type 1 diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Fresno, California, 93721, United States
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Merced, California, 95340, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
San Clemente, California, 92679, United States
Unknown Facility
San Mateo, California, 94403, United States
Unknown Facility
Englewood, Colorado, 80113, United States
Unknown Facility
Littleton, Colorado, 80120, United States
Unknown Facility
Hartford, Connecticut, 06015, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Downers Grove, Illinois, 60515, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Indianapolis, Indiana, 46237, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Louisville, Kentucky, 40202-1798, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Portland, Maine, 04102, United States
Unknown Facility
Baltimore, Maryland, 21229, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Burlington, Massachusetts, 01805, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Detroit, Michigan, 48202-2689, United States
Unknown Facility
Duluth, Minnesota, 55805, United States
Unknown Facility
Tupelo, Mississippi, 38801, United States
Unknown Facility
Kansas City, Missouri, 64128, United States
Unknown Facility
St Louis, Missouri, 63110-0250, United States
Unknown Facility
Lebanon, New Hampshire, 03756, United States
Unknown Facility
Egg Harbour Township, New Jersey, 08234, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Bayside, New York, 11358, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10029-6574, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Unknown Facility
Charlotte, North Carolina, 28203, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Dayton, Ohio, 45415, United States
Unknown Facility
Tulsa, Oklahoma, 74104, United States
Unknown Facility
Portland, Oregon, 97227, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Nashville, Tennessee, 37211, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
West Nashville, Tennessee, 37205, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Fort Sam Houston, Texas, 78234-3879, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Lubbock, Texas, 79410, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Charlottesville, Virginia, 22906-0013, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
San Juan, 00936-5067, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
January 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
May 7, 2012
Results First Posted
May 7, 2012
Record last verified: 2012-04