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...
Date First Received: March 2, 2006
Last Updated: November 21, 2007
Verified by: Hospital Clinic of Barcelona, November 2007
Clinical Trial Phase: Phase 4 | Start Date: March 2003
Overall Status: Completed
Estimated Enrollment: 20
Brief Summary
Official Title: “Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Intervention(s) in this Clinical Trial
- Drug: Losartan
Outcome Measures for this Clinical Trial
Primary Measures
- Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 35 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hospital Clinic of Barcelona
Overall Clinical Trial Officials and Contacts
Pere Ginès, M.D. Principal Investigator Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00298714
Study ID Number: ARAHEPC
ClinicalTrials.gov Identifier: NCT00298714
Health Authority: Spain: Spanish Agency of Medicines
Clinical Trials Authorship and Review
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