Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).

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.

Timeline

Start

2019-08-01

Primary completion

2023-12-01

Completion

2024-01-01

Publications

• Cerda-Reyes E, de la Rosa-Bibiano R, Sandoval-Rodriguez A, Rosas-Campos R, Torre A, Cornejo-Hernandez S, Escutia-Gutierrez R, Vazquez-Esqueda A, Gutierrez-Cuevas J, Gutierrez-Atemis A, Amezquita-Perez S, Poo JL, Garrido-Sanchez GA, Bastida-Alquicira J, Saldana-Rivera E, Lozano-Trenado LM, Ramon-Aguilar J, Madrigal JA, Armendariz-Borunda J. HCV patients with residual fibrosis after DAA treatment re-establish their epigenetic signature after prolonged-release pirfenidone: MINERVA study. Clin Epigenetics. 2025 Oct 3;17(1):157. doi: 10.1186/s13148-025-01969-y.

Drugs

Indications