NCT03963895

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of a Single Dose of E-WE Thrombin, Administered During a Regular Hemodialysis Procedure, in Patients With End-Stage Renal Disease on Chronic Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aronora, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• End Stage Renal Disease
• Thrombosis

Interventions

Type	Name	Description
DRUG	AB002 Dose 1	AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion
DRUG	AB002 Dose 2	AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion
DRUG	placebo	placebo administered on Day 1 as a single intravenous infusion

Timeline

• Start date: 2019-07-03
• Primary completion: 2020-12-29
• Completion: 2020-12-29
• First posted: 2019-05-28
• Last updated: 2024-03-07
• Results posted: 2022-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study