Pirfenidone, an Antifibrotic and Antiinflammatory Drug

University of Guadalajara

Status and phase: Completed; Phase 2

Conditions: Fibrosis; Hepatitis C Chronic

Treatments: Drug: Pirfenidone; Drug: Matched equivalent placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02161952

HCG, No. Registry 505/05 (Registry Identifier)

IBMMTG.05

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Pirfenidone

Experimental group

Description:

Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.

Treatment:

Drug: Pirfenidone

Matched equivalent placebo

Placebo Comparator group

Description:

Matched equivalent placebo

Treatment:

Drug: Matched equivalent placebo