Pirfenidone (PFD), an oral antifibrotic drug with anti-inflammatory and anti-oxidant
properties, has been granted marketing authorization by the European Medicine Agency and FDA,
for the treatment of idiopathic pulmonary fibrosis (IPF). However, few studies have focused
on its clinical utilization in patients with advanced hepatic fibrosis. Therefore,
Investigators aim to evaluate a prolonged-release PFD formulation (PR-PFD) plus standard of
care management on disease progression in patients with advanced liver fibrosis (ALF).
Methods: Patients with diverse chronic liver disease etiology (alcohol-related, hepatitis B
or C, autoimmune or fatty liver disease) will be screened with two non invasive liver
fibrosis methods (Fibroscan®) and Fibro Test®) and those with ALF (F3 or F4) will be treated
for at least 12 months with PR-PFD. Antifibrotic effects Will be assessed at 6 and 12 months;
variations greater than 30% in estimated fibrosis scores or 1 point on the METAVIR scale will
be considered clinically significant. PFD plasma levels, serum endothelin-1, IL6, TNFα and
TGFβ1, Quality of life and fatigue scales will be evaluated. Parametric and non parametric
statistics will be utilized and p values lower tan 5% will be considered clinically
significant.
Phase:
Phase 2
Details
Lead Sponsor:
Grupo Mexicano para el Estudios de las Enfermedades Hepaticas