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Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00298714
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00298714     History of Changes
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:
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
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
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action