Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).
Mexico60 participantsStarted 2019-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with a history of Chronic Viral Hepatitis C, of all genotypes, demonstrated with previous studies (positive viral load).
✓. History of treatment with direct acting antivirals (AAD).
✓. Demonstration of negative viral load at least 6 months after completing treatment with AAD, considered as sustained viral response (SVR).
✓. Fibrotest and / or Liver Elastography test with advanced liver fibrosis scores (F3-F4).
✓. Verification of advanced liver fibrosis in a liver biopsy.
✓. Patients with Child Pugh functional class A or B and in stable clinical conditions (without active variceal hemorrhage, ascites or refractory encephalopathy) with consumption of drugs at stable doses in at least 30 days.
✓. Laboratory tests that confirm her condition and functional class, with results that, in the opinion of the main researcher, do not put the patient at risk:
Exclusion criteria
✕. Child Pugh functional class C (≥ 10 points)