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

MedlinePlus related topics:   Hepatitis   Hepatitis C  

ChemIDplus related topics:   Losartan potassium   Losartan  

U.S. FDA Resources

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.

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    
Hospital Clinic of Barcelona
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

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

Keywords provided by Hospital Clinic of Barcelona:
Hepatitis C, Chronic  

Study placed in the following topic categories:
Hepatitis
Losartan
Liver Diseases
Hepatic fibrosis
Hepatitis, Chronic
Fibrosis
Hepatitis, Viral, Human
Liver Cirrhosis
Hepatitis C
Angiotensin II
Hepatitis C, Chronic

Additional relevant MeSH terms:
Hepatitis C, Chronic
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Virus Diseases
Angiotensin II Type 1 Receptor Blockers
Pathologic Processes
Digestive System Diseases
Therapeutic Uses
Anti-Arrhythmia Agents

Source: National Library of Medicine (NLM) July 03, 2008

  


 
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