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)
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
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Veterans Administration Medical Center GI Section (111B)
🇺🇸San Francisco, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
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