Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Prolonged-Release Pirfenidone (PR-PFD) is an anti-fibrogenic and anti-inflammatory molecule
used for the treatment of idiopathic pulmonary fibrosis (approved by FDA) and liver fibrosis
(approved in Mexico by COFEPRIS). PFD effects are mediated in part through inhibition of
TGFβ, TNFα, IL-1 and IL-6, along with NFκB activation down-regulation causing reduced TNFα
and IFNγ levels.
The aim of this protocol is to know if the epigenetic factors induced by PR-PFD have a
regulatory role to understand the progression variants in liver fibrosis in a group of
patients with viral hepatitis C, with a history of sustained viral response and advanced
residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone
(KitosCell® LP), in patients with compensated liver cirrhosis.