Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Phase 2CompletedNCT02161952

University of Guadalajara150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Fibrosis Hepatitis C Chronic

Interventions

PirfenidoneDRUG

Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.

Matched equivalent placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Fibrosis staging

Fibrosis was evaluated according to Ishak fibrosis staging scale.

Time frame: 24 months

Secondary Outcomes

Grade of necroinflammation activity

Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).

Time frame: 24 months

Data from ClinicalTrials.gov

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