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Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298714
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : November 22, 2007
Information provided by:
Hospital Clinic of Barcelona

Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Liver Fibrosis Drug: Losartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
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.
Study Start Date : March 2003
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298714

Sponsors and Collaborators
Hospital Clinic of Barcelona
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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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00298714    
Other Study ID Numbers: ARAHEPC
Protocol number: 02-0491
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007
Keywords provided by Hospital Clinic of Barcelona:
Hepatitis C, Chronic
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Flaviviridae Infections
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action