NCT02230683

A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension

An Open-Label Pilot Trial to Evaluate the Safety, Tolerability and Efficacy of IDN-6556 in Cirrhotic Subjects With Portal Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.

Detailed description

Studies in patients with liver disease have demonstrated that cCK18 is elevated in the serum of patients and has been associated with disease severity. Studies have also shown that cCK18 is generally elevated to a higher degree in cirrhosis than in other liver diseases. In addition, increasing stages of cirrhosis from Child-Pugh A, Child-Pugh B to Child-Pugh C are associated with progressively higher levels of caspase cleaved cytokeratin 18. This suggests that apoptosis and caspase activity are associated with the severity of disease. IDN-6556 and its ability to inhibit inflammation and apoptosis may have a beneficial impact on both the dynamic and structural components associated with the pathogenesis of portal hypertension in cirrhosis.

Conditions

• Liver Cirrhosis
• Hepatic Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	IDN-6556	25 mg BID

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2014-09-03
• Last updated: 2016-12-21
• Results posted: 2016-12-21

Locations

16 sites across 1 country: United States