Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

This study has been completed.

First Received: March 2, 2006 Last Updated: November 21, 2007 History of Changes

Sponsor:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00298714

Purpose

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	Intervention	Phase
Chronic Hepatitis C Liver Fibrosis	Drug: Losartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	March 2003
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298714

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

More Information

No publications provided

Study ID Numbers:	ARAHEPC, Protocol number: 02-0491
Study First Received:	March 2, 2006
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00298714 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

Hepatitis C, Chronic

Additional relevant MeSH terms:

Losartan
Liver Diseases
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Flaviviridae Infections
Fibrosis
Hepatitis, Viral, Human
Cardiovascular Agents
Liver Cirrhosis
Antihypertensive Agents

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Hepatitis
Virus Diseases
Pathologic Processes
Digestive System Diseases
Therapeutic Uses
Anti-Arrhythmia Agents
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on February 08, 2010