Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT00298714

Collaborator

(none)

Enrollment

34.1

Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Liver Fibrosis	Drug: Losartan	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2003

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator: Pere Ginès, M.D., Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
Study Chair: Vicente Arroyo, M.D., Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona