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Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

This study has been completed.
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: March 2, 2006
Last updated: November 21, 2007
Last verified: November 2007

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 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

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

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00298714

Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00298714     History of Changes
Other Study ID Numbers: ARAHEPC
Protocol number: 02-0491
Study First Received: March 2, 2006
Last Updated: November 21, 2007

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017