Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298714
• Other study ID #: ARAHEPC
• Secondary ID: Protocol number:
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: November 21, 2007
• Start date: March 2003
• Est. completion date: January 2006

Study information

• Verified date: November 2007
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Drug:
• Losartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.