Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C
Information source: Hospital Clinic of Barcelona
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C; Liver Fibrosis
Intervention: Losartan (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s):
Pere Ginès, M.D., Principal Investigator, Affiliation: Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
Vicente Arroyo, M.D., Study Chair, Affiliation: Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
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).
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.
Eligibility
Minimum age: 35 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: March 2003
Ending date: January 2006
Last updated: November 21, 2007
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