NCT00148837

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

February 8, 2008

Status Verified

February 1, 2008

First QC Date

September 7, 2005

Last Update Submit

February 6, 2008

Conditions

Hepatitis C, ChronicFibrosis

Keywords

Hepatitis C, ChronicFibrosisInterferon Alfa-2bRibavirinPrazosin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96

  • Sustained virological response: undetectable HCV RNA at W96

  • Sustained biochemical response: ALT level at W96

Interventions

Peg-interferon alpha 2b (drug)DRUG
Ribavirin (drug)DRUG
Prazosin (drug)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic viral hepatitis C, genotype 1 or 4
  • Fibrosis F3 or F3-F4, assessed by the scoring Metavir system
  • Initial treatment against HCV

You may not qualify if:

  • Psychiatric pathology
  • Alcool consummation
  • Pregnancy or plan of pregnancy
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du haut Leveque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Hepatitis C, ChronicFibrosis

Interventions

Pharmaceutical PreparationsRibavirinPrazosin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • de Ledinghen Victor, MD, PhD

    Hopital du Haut-Leveque, Service d'Hepato-Gastroenterologie, Pessac 33604, France

    PRINCIPAL INVESTIGATOR

  • Chene Genevieve, MD, PhD

    INSERM Unite 593, Bordeaux, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

September 1, 2004

Last Updated

February 8, 2008

Record last verified: 2008-02

Locations

FR(1)