search
Back to results

Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Primary Purpose

Chronic Hepatitis C, Liver Fibrosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Losartan
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C, Chronic

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age between 35 and 65 years chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score). non-responder or contraindication to antiviral therapy. Exclusion Criteria: any other cause of liver disease HIV positive alcohol consumption arterial hypertension creatinine > 1.5mg/dL treatment with AT1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months. antiviral therapy in the past 12 months contraindications to oral losartan

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2006
    Last Updated
    November 21, 2007
    Sponsor
    Hospital Clinic of Barcelona
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00298714
    Brief Title
    Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C
    Official Title
    Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Clinic of Barcelona

    4. Oversight

    5. Study Description

    Brief Summary
    There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis. The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C, Liver Fibrosis
    Keywords
    Hepatitis C, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Losartan
    Primary Outcome Measure Information:
    Title
    Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 35 and 65 years chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score). non-responder or contraindication to antiviral therapy. Exclusion Criteria: any other cause of liver disease HIV positive alcohol consumption arterial hypertension creatinine > 1.5mg/dL treatment with AT1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months. antiviral therapy in the past 12 months contraindications to oral losartan
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pere Ginès, M.D.
    Organizational Affiliation
    Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Vicente Arroyo, M.D.
    Organizational Affiliation
    Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19628656
    Citation
    Colmenero J, Bataller R, Sancho-Bru P, Dominguez M, Moreno M, Forns X, Bruguera M, Arroyo V, Brenner DA, Gines P. Effects of losartan on hepatic expression of nonphagocytic NADPH oxidase and fibrogenic genes in patients with chronic hepatitis C. Am J Physiol Gastrointest Liver Physiol. 2009 Oct;297(4):G726-34. doi: 10.1152/ajpgi.00162.2009. Epub 2009 Jul 23.
    Results Reference
    derived

    Learn more about this trial

    Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

    We'll reach out to this number within 24 hrs