Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Phase 2

Completed

• Conditions: Fibrosis; Hepatitis C Chronic
• Interventions: Drug: Pirfenidone; Drug: Matched equivalent placebo

• Registration Number: NCT02161952
• Lead Sponsor: University of Guadalajara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-08
• Study Completion: 2007-08
• Status Verified: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Read More

Exclusion Criteria

• Patients with clinical contraindications to hepatic biopsy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirfenidone	Pirfenidone	Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
Matched equivalent placebo	Matched equivalent placebo	Matched equivalent placebo

Primary Outcome Measures

Name	Time	Method
Fibrosis staging	24 months	Fibrosis was evaluated according to Ishak fibrosis staging scale.

Secondary Outcome Measures

Name	Time	Method
Grade of necroinflammation activity	24 months	Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).