Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039962
Status:
COMPLETED
Last Update Posted:
2008-01-15
First Post:
2002-06-17
Brief Title:
Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Sponsor:
SciClone Pharmaceuticals
Organization:
SciClone Pharmaceuticals
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 16 mg twice weekly plus PEGinterferon alfa-2a 180 ugwk 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
This is a randomized double-blinded multicenter trial to determine the effectiveness of thymosin alpha 1 thymalfasin 16 mg twice weekly plus PEGinterferon alfa-2a 180 ugwk 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None