Conditions: Liver Cirrhosis Hepatic Cirrhosis Portal Hypertension
Keywords: Liver Cirrhosis Hepatic Cirrhosis Portal Hypertension
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Overall evaluable population treated with IDN-6556 25 mg twice daily arm 2: Subgroup for patients with Baseline HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily arm 3: Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily

Interventions: intervention 1: IDN-6556
Intervention descriptions: intervention 1: 25 mg BID

Protocol document: