Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

NCT00298714 | Completed Phase 4

• 2 other identifiers: ARAHEPCProtocol number: 02-0491
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Hepatitis C; Liver Fibrosis

Keywords

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

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

Interventions

Losartan DRUG

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 35 and 65 years
• chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score).
• non-responder or contraindication to antiviral therapy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Related Publications (1)

• Colmenero J, Bataller R, Sancho-Bru P, Dominguez M, Moreno M, Forns X, Bruguera M, Arroyo V, Brenner DA, Gines P. Effects of losartan on hepatic expression of nonphagocytic NADPH oxidase and fibrogenic genes in patients with chronic hepatitis C. Am J Physiol Gastrointest Liver Physiol. 2009 Oct;297(4):G726-34. doi: 10.1152/ajpgi.00162.2009. Epub 2009 Jul 23.

  PMID: 19628656 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Cirrhosis

Interventions

Losartan

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Pere Ginès, M.D.

  Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona

  PRINCIPAL INVESTIGATOR

• Vicente Arroyo, M.D.

  Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 3, 2006
• Study Start: March 1, 2003
• Study Completion: January 1, 2006
• Last Updated: November 22, 2007

Record last verified: 2007-11