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.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); Copegus (Drug); Pioglitazone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

Overall contact:
Please reference Study ID Number: ML21301, Phone: 973-235-5000

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 1000-1600mg/day (according to body weight) or b)16 weeks of pioglitazone (30mg daily for 8 weeks, then 45mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600mg/day + pioglitazone 45mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Official title: 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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HCV RNA

Secondary outcome:

Percentage of patients with undetectable HCV RNA, percentage of patients with >2log10 decrease in HCV RNA, change in log10 HCV RNA.

Glycemic and lipid control, and insulin resistance.

AEs, laboratory parameters, beta-type natriuretic peptide

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- chronic hepatitis C, genotype 1;

- insulin resistance.

Exclusion Criteria:

- other forms of liver disease;

- cirrhosis;

- previous treatment for chronic hepatitis C;

- insulin treatment during prior 2 weeks;

- type 1 diabetes.

Please reference Study ID Number: ML21301, Phone: 973-235-5000

SAN JUAN 00936-5067, Puerto Rico; Not yet recruiting

BIRMINGHAM, Alabama 35294, United States; Active, not recruiting

TUCSON, Arizona 85710, United States; Recruiting

LA JOLLA, California 92037, United States; Recruiting

FRESNO, California 93702, United States; Recruiting

LOMA LINDA, California 92354, United States; Recruiting

SAN CLEMENTE, California 92679, United States; Recruiting

SAN MATEO, California 94403, United States; Recruiting

LOS ANGELES, California 90048, United States; Recruiting

PALO ALTO, California 94304, United States; Recruiting

ANAHEIM, California 92801, United States; Recruiting

PASADENA, California 91105, United States; Recruiting

MERCED, California 95340, United States; Recruiting

LITTLETON, Colorado 80120, United States; Recruiting

ENGLEWOOD, Colorado 80113, United States; Recruiting

HARTFORD, Connecticut 06015, United States; Recruiting

ATLANTA, Georgia 30308, United States; Recruiting

ATLANTA, Georgia 30322, United States; Not yet recruiting

MARIETTA, Georgia 30060, United States; Not yet recruiting

CHICAGO, Illinois 60612, United States; Recruiting

DOWNERS GROVE, Illinois 60515, United States; Recruiting

INDIANAPOLIS, Indiana 46237, United States; Recruiting

INDIANAPOLIS, Indiana 46202, United States; Not yet recruiting

IOWA CITY, Iowa 52242, United States; Terminated

LOUISVILLE, Kentucky 40202, United States; Recruiting

NEW ORLEANS, Louisiana 70112, United States; Recruiting

PORTLAND, Maine 04102, United States; Recruiting

BALTIMORE, Maryland 21229, United States; Recruiting

BURLINGTON, Massachusetts 01805, United States; Recruiting

BOSTON, Massachusetts 02215, United States; Recruiting

DETROIT, Michigan 48202-2689, United States; Recruiting

DETROIT, Michigan 48201, United States; Not yet recruiting

DULUTH, Minnesota 55805, United States; Recruiting

TUPELO, Mississippi 38801, United States; Recruiting

KANSAS CITY, Missouri 64128, United States; Recruiting

LEBANON, New Hampshire 03756, United States; Recruiting

EGG HARBOUR TOWNSHIP, New Jersey 08234, United States; Recruiting

HACKENSACK, New Jersey 07061, United States; Recruiting

NEW YORK, New York 10021, United States; Recruiting

NEW YORK, New York 10029, United States; Recruiting

BAYSIDE, New York 11358, United States; Recruiting

MANHASSET, New York 11030, United States; Recruiting

NEW YORK, New York 10003, United States; Not yet recruiting

ASHEVILLE, North Carolina 28801, United States; Recruiting

DURHAM, North Carolina 27710, United States; Recruiting

CHARLOTTE, North Carolina 28203, United States; Recruiting

CINCINNATI, Ohio 45219, United States; Recruiting

CINCINNATI, Ohio 45267, United States; Not yet recruiting

CINCINNATI, Ohio 45242, United States; Recruiting

CLEVELAND, Ohio 44106, United States; Recruiting

DAYTON, Ohio 45415, United States; Recruiting

CLEVELAND, Ohio 44106-5066, United States; Not yet recruiting

TULSA, Oklahoma 74104, United States; Recruiting

PORTLAND, Oregon 97239, United States; Not yet recruiting

PORTLAND, Oregon 97227, United States; Recruiting

PHILADELPHIA, Pennsylvania 19140, United States; Recruiting

PHILADELPHIA, Pennsylvania 19141, United States; Recruiting

COLUMBIA, South Carolina 29203, United States; Recruiting

NASHVILLE, Tennessee 37232, United States; Recruiting

NASHVILLE, Tennessee 37211, United States; Recruiting

WEST NASHVILLE, Tennessee 37205, United States; Recruiting

NASHVILLE, Tennessee 37203, United States; Not yet recruiting

GERMANTOWN, Tennessee 38138, United States; Not yet recruiting

LUBBOCK, Texas 79410, United States; Recruiting

HOUSTON, Texas 77030, United States; Recruiting

DALLAS, Texas 75246, United States; Recruiting

FORT SAM HOUSTON, Texas 78234-3879, United States; Recruiting

SALT LAKE CITY, Utah 84132, United States; Recruiting

CHARLOTTESVILLE, Virginia 22906-0013, United States; Recruiting

SEATTLE, Washington 98101, United States; Not yet recruiting

TACOMA, Washington 98405, United States; Active, not recruiting

Starting date: November 2007
Ending date: November 2010
Last updated: January 15, 2009