Phase IV Study of Long Term Peg-Intron for Patients Who Have Failed to Respond to Rebetron/Interferon With Advanced Fibrosis and Cirrhosis Secondary to Hepatitis C- The Copilot Trial
We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine
0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron &
Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced
fibrosis/cirrhosis. The specific aims of this proposal are to evaluate the role of long
term Peg-Intron therapy on the natural history of patients with advanced chronic HCV
infection with a primary focus on prevention of hepatic decompensation, progression of
fibrosis and hepatoma development.
The study design will focus on 3 monthly clinical evaluation for decompensation of liver
function, rigorous clinical screening for development of hepatocellular cancer and liver
biopsies for determination of progression of liver fibrosis every second year.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Determination of the effect of PEG-Intron 0.5mg per kg weekly sc versus colchicine 0.6mg bid daily on:
Nezam H Afdhal, MD
Principal Investigator
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
2001-P-000002
NCT00179413
January 2001
December 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Temple University Hospital | Philadelphia, Pennsylvania 19140 |
Columbia University | New York, New York 10032-3784 |
University of Colorado Health Sciences Center | Denver, Colorado 80262 |
Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Georgetown University Medical Center | Washington, District of Columbia 20007 |
Texas Transplant Institute | San Antonio, Texas 78229 |
Danbury Hospital | Danbury, Connecticut 06810 |
Fallon Clinic | Worcester, Massachusetts 01605 |
Birmingham Gastroenterology Associates | Birmingham, Alabama 35209 |
UAMS Medical Center | Little Rock, Arkansas 72205 |
34th Street Community Health Center | Bakersfield, California 93301-1645 |
UC Davis Medical Center | Sacramento, California 95817 |
Kaiser Permanende-GI Department | Sacramento, California 95825 |
Gastroenterology Associates | San Diego, California 92115 |
Bruce Stein, MD | Manchester, Connecticut 06040 |
Connecticut Gastroenterology Consultants | New Haven, Connecticut 06510 |
Bach and Godofsky Infectious Disease | Bradenton, Florida 34205 |
Southern Clinical Research Consultants | Hollywood, Florida 33021 |
Gastroenterology Associates of South Florida | S. Miami, Florida 33143 |
Digestive Health Services | Downers Grove, Illinois 60515 |
Digestive Disease Associates | Baltimore, Maryland 21229 |
Hampshire Gastroenterology | Florence, Massachusetts 01062 |
Wayne State University/Haper Hospital | Detroit, Michigan 48601 |
Gastroenterology Division Veterans Affairs Medical Center | Minneapolis, Minnesota 55417 |
Minnesota Gastroenterology | Plymouth, Minnesota 55446 |
Gastroenterology Associates | Kansas City, Missouri 64131 |
VA New Jersey Healthcare System | East Orange, New Jersey 07018 |
Atlantic Gastroenterology | Egg Harbor, New Jersey 08234 |
Florham Park Endoscopy Center | Florham Park, New Jersey 07932 |
Northern New Mexico Gastroenterology | Santa Fe, New Mexico 87505 |
Dr. Sam Moskowitz, MD, PC | Forest Hills, New York 11375 |
Liberty Medical, LLP | New York, New York 10003 |
Metro Medical | New York, New York 10011 |
Peter Varunok, MD | Poughkeepsie, New York 12601 |
Upstate Medical Center | Syracuse, New York 13210 |
Guthrie Research Foundation | Sayre, Pennsylvania 18840 |
University Gastroenterologists | Providence, Rhode Island 02905 |
Nashville Gastroenterology Specialists Incorporated | Nashville, Tennessee 37211 |
Austin Gastroenterology | Austin, Texas 78745 |
G.I. and Liver Associates | Granbury, Texas 76048 |
Digestive Disease Center | San Antonio, Texas 78205 |
Health Science Center | Salt Lake City, Utah 84132 |
Medical Center of Wisconsin | Milwaukee, Wisconsin 53226 |