A Study of IDN-6556 in Subjects With Liver Cirrhosis

Phase 2 Completed 87 enrolled Conatus Pharmaceuticals Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter study to see if treatment with IDN-6556 can help improve the liver function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores between 11-18.

Timeline

Start: 2014-08
Primary completion: 2016-01
Completion: 2016-01

Outcome

Missed primary endpoint

registry analysis (superiority test); IDN-6556 vs Placebo; p = 0.091; Mean Difference (Final Values) -0.140 (95% CI -0.302 to 0.023); ANCOVA NCT02230670 ↗

paper Serum levels of full-length CK-18 (P = .02) and caspase 3/7 (P < .001), but not cleaved CK-18 (P = .092), decreased significantly PMID 29913280 ↗

Publications

Frenette CT, Morelli G, Shiffman ML, Frederick RT, Rubin RA, Fallon MB, Cheng JT, Cave M, Khaderi SA, Massoud O, Pyrsopoulos N, Park JS, Robinson JM, Yamashita M, Spada AP, Chan JL, Hagerty DT. Emricasan Improves Liver Function in Patients With Cirrhosis and High Model for End-Stage Liver Disease Scores Compared With Placebo. Clin Gastroenterol Hepatol. 2019 Mar;17(4):774-783.e4. doi: 10.1016/j.cgh.2018.06.012. Epub 2018 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Emricasan	Small molecule	25 mg	—