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Sponsored by: |
SciClone Pharmaceuticals |
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Information provided by: | SciClone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00039962 |
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 with early cirrhosis or progression to 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
Condition | Intervention | Phase |
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Hepatitis C Hepatitis C, Chronic |
Drug: thymalfasin (thymosin alpha 1) Drug: PEGinterferon alfa-2a |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | Ta1-CHC-2K0804 |
Study First Received: | June 17, 2002 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00039962 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hepatitis C hepatitis C, chronic cirrhosis, liver |
Anti-Infective Agents Liver Diseases Immunologic Factors Hepatitis, Chronic Ribavirin Interferons Adjuvants, Immunologic Hepatitis, Viral, Human Liver Cirrhosis |
Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Thymalfasin Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic |
Anti-Infective Agents Liver Diseases RNA Virus Infections Immunologic Factors Flaviviridae Infections Hepatitis, Chronic Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Thymalfasin Therapeutic Uses Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic |