Pirfenidone, an Antifibrotic and Antiinflammatory Drug

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.

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Key information

Conditions

Fibrosis Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C Chronic Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

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.

Other names: 5 methyl-1-phenil-2 (1H)-pyridone

Matched equivalent placebo

Drug

Primary outcomes

Fibrosis staging

Time frame: 24 months

Fibrosis was evaluated according to Ishak fibrosis staging scale.

Secondary outcomes

Grade of necroinflammation activity

Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

Cell Therapy And Technology, S.a. De C.v.

Registry information

Official study title

Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Jun 12, 2014
Registry last updated: Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed