Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
- Conditions
- Hepatitis CHepatitis C, Chronic
- Registration Number
- NCT00040027
- Lead Sponsor
- SciClone Pharmaceuticals
- Brief Summary
Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders.
This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Center for Digestive and Liver Health
🇺🇸Savannah, Georgia, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Metro Health Medical Center, GI Division
🇺🇸Cleveland, Ohio, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Ponce School of Medicine
🇵🇷Ponce, Puerto Rico
University of Miami Center for Liver Diseases
🇺🇸Miami, Florida, United States
Baylor, VAMC
🇺🇸Houston, Texas, United States
University of Alabama - Knollwood Physician's Group Bldg.
🇺🇸Mobile, Alabama, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Gastroenterology Associates of East Bay Medical Group
🇺🇸Berkeley, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Chicago Hospital & Clinic
🇺🇸Chicago, Illinois, United States
Hepatitis C Treatment Centers, Inc.
🇺🇸Louisville, Kentucky, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Bronx VA Medical Center
🇺🇸New York, New York, United States
Roger Williams Medical Center
🇺🇸Providence, Rhode Island, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Idaho Gastroenterology Associates
🇺🇸Meridian, Idaho, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
New England Medical Center
🇺🇸Boston, Massachusetts, United States
Mississippi Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Saint Louis University Hospital
🇺🇸SainT Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
NY VAMC
🇺🇸New York, New York, United States
NYU Hospitals Center
🇺🇸New York, New York, United States
Carolinas Center for Liver Diseases
🇺🇸Charlotte, North Carolina, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
GI Center MidSouth
🇺🇸Memphis, Tennessee, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Tennessee Gastroenterology
🇺🇸Memphis, Tennessee, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Veterans Administration Medical Center GI Section (111B)
🇺🇸San Francisco, California, United States
Liver Research Center - University of Louisville
🇺🇸Louisville, Kentucky, United States
VAMC
🇺🇸Kansas City, Missouri, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
University of Cincinnati - College of Medicine
🇺🇸Cincinnati, Ohio, United States
University of Florida
🇺🇸Gainesville, Florida, United States
McGuire Research Institute
🇺🇸Richmond, Virginia, United States
Louisiana State University Healthcare Network
🇺🇸New Orleans, Louisiana, United States