Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119119
Status:
TERMINATED
Last Update Posted:
2007-01-12
First Post:
2005-07-04
Brief Title:
Efficacy and Safety of Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C
Status:
TERMINATED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The fibrosis of liver is a complication of chronic hepatitis C There is actually no established treatment for fibrosis of the liver Pentoxyphilline and tocopherol may have an activity on fibrosis The aim of the study is to analyse the efficacy and the safety of the combination with pentoxyphilline and tocopherol 12 months on liver fibrosis in patients with chronic hepatitis C who are non-long-term responders or with intolerance or contra-indication to interferon-alfa and ribavirin
Detailed Description:
The aim of this study is to analyse the efficacy and the safety of the combination of pentoxyphilline 400 mg twice a day and tocopherol 500 mg twice a day given during 12 months on the fibrosis related to HCV chronic hepatitis in 100 patients who are non-long-term responders or with contra-indication or intolerance to the current treatment of reference combination with interferon-alfa and ribavirin It is a therapeutic national multicentric double-blind placebo-controlled phase III trial The patients included had histological liver injuries with a Metavir score of A 0 to 2 F 2 or 3 and no other etiology of liver disease The primary objective is to analyse the variation of the liver fibrosis evaluated by morphometric analysis between the 2 liver biopsies performed at the end of the trial and within 3 years before the treatment The secondary objectives are the variation of the Metavir fibrosis and activity scores of serum markers of fibrosis hyaluronate PIIIP TNF-alfa fibrotest and ALT between the end and the beginning of the treatment
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