Hepatitis C, Chronic Clinical Trial
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
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.
Status | Active, not recruiting |
Enrollment | 112 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic viral hepatitis C, genotype 1 or 4 - Fibrosis F3 or F3-F4, assessed by the scoring Metavir system - Initial treatment against HCV Exclusion Criteria: - Psychiatric pathology - Alcool consummation - Pregnancy or plan of pregnancy - Breastfeeding |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital du haut Leveque | Pessac |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients presenting a decrease of fibrosis as measured on the liver biopsy and considered as clinically interesting (decrease of fibrosis pre- and post-therapeutic (W96) measures of at least 10 percent) | |||
Secondary | Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96 | |||
Secondary | Sustained virological response: undetectable HCV RNA at W96 | |||
Secondary | Sustained biochemical response: ALT level at W96 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03740906 -
Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting
|
||
Terminated |
NCT02465203 -
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
|
Phase 3 | |
Completed |
NCT02262728 -
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
|
Phase 2 | |
Completed |
NCT01429792 -
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
|
Phase 4 | |
Completed |
NCT02541409 -
Directly Observed Therapy for HCV in Chennai, India
|
Phase 2 | |
Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
Withdrawn |
NCT01608737 -
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
|
Phase 3 | |
Completed |
NCT01399619 -
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
|
Phase 3 | |
Completed |
NCT02113631 -
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
|
N/A | |
Completed |
NCT01435226 -
GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection
|
Phase 2 | |
Completed |
NCT01435044 -
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
|
Phase 2 | |
Completed |
NCT01447446 -
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
|
N/A | |
Terminated |
NCT01168856 -
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
|
N/A | |
Completed |
NCT00725751 -
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
|
N/A | |
Completed |
NCT00793793 -
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
|
Phase 1 | |
Completed |
NCT00377182 -
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
|
Phase 2 | |
Completed |
NCT00375661 -
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
|
Phase 4 | |
Completed |
NCT00704717 -
Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)
|
N/A | |
Completed |
NCT00723632 -
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
|
N/A |