Pirfenidone, an Antifibrotic and Antiinflammatory Drug

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Guadalajara
• Collaborator: Cell Therapy And Technology, S.a. De C.v.
• Treatments: Anti-Inflammatory Agents; Pirfenidone

Criteria

Inclusion Criteria:

• Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).

• Sign an informed consent form to allow the collection of liver biopsies before and after treatment.

• No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.

• No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Exclusion Criteria:

• Patients with clinical contraindications to hepatic biopsy