Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Hepatitis C Liver Fibrosis

Keywords

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Losartan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pere Ginès, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Vicente Arroyo, M.D.

Role: STUDY_CHAIR

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

References

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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.

Reference Type DERIVED

PMID: 19628656 (View on PubMed)

Other Identifiers

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Protocol number: 02-0491

Identifier Type: -

Identifier Source: secondary_id

ARAHEPC