Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis.

Summary

This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov.

Timeline

Start

2015-06-26

Primary completion

2021-12-30

Completion

2023-03-24

Drugs

Indications