Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148837
Status:
UNKNOWN
Last Update Posted:
2008-02-08
First Post:
2005-09-07
Brief Title:
Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
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:
Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
Status:
UNKNOWN
Status Verified Date:
2008-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress in patients with chronic hepatitis C and severe fibrosis
Detailed Description:
Treatment of hepatitis C with interferon and ribavirin has a virological effect Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer In vitro studies of prazosin suggest an effect against hepatic fibrosis but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis C infection is unknown The purpose of this multicentric national study is to compare the effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or not placebo 112 patients with a viral hepatitis C genotype 1 or 4 and severe fibrosis will be randomly assigned to one of two treatment groups peg-interferon alpha 2b and ribavirin with prazosin or with placebo Peg-interferon alpha 2b will be administered once a week 15 micro g per kg during 48 weeks ribavirin 1000 to 1200 mg per day according to weight during 48 weeks prazosinplacebo 5 mg 2 pills per day during 96 weeks Evaluation will be done at 96 weeks The primary end-point is the proportion of patients presenting a decrease of fibrosis Secondary end-points are other criteria of histological response virological response biochemical response
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRSHC17 Prazor | None | None | None |