Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis

Summary

This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB002 (E-WE thrombin) or placebo (at a ratio of 2:1 active: placebo).

Timeline

Start

2019-07-03

Primary completion

2020-12-29

Completion

2020-12-29

Publications

• Verbout NG, Lorentz CU, Markway BD, Wallisch M, Marbury TC, Di Cera E, Shatzel JJ, Gruber A, Tucker EI. Safety and tolerability of the protein C activator AB002 in end-stage renal disease patients on hemodialysis: a randomized phase 2 trial. Commun Med (Lond). 2024 Jul 26;4(1):153. doi: 10.1038/s43856-024-00575-y.
• Tucker EI, Verbout NG, Markway BD, Wallisch M, Lorentz CU, Hinds MT, Shatzel JJ, Pelc LA, Wood DC, McCarty OJT, Di Cera E, Gruber A. The protein C activator AB002 rapidly interrupts thrombus development in baboons. Blood. 2020 Feb 27;135(9):689-699. doi: 10.1182/blood.2019002771.

Drugs

Indications