CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
AB002 Dose 1 +2 moredrug
Likely dose
AB002 Dose 1 1.5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03963895
NCT03963895Phase 2Completed
CompareCT.gov

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

Aronora, Inc.·interventional·Posted May 28, 2019·Updated Mar 7, 2024

In Brief

A Phase 2 clinical trial evaluating AB002 Dose 1, AB002 Dose 2, and 1 other intervention for End Stage Renal Disease and Thrombosis. Completed, enrolled 40 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Thrombosis
CountriesUnited States
CollaboratorsCelerion

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 28, 2019
Enrollment StartJul 3, 2019
Primary CompletionDec 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago

Interventions

AB002 Dose 1drug

AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion

AB002 Dose 2drug

AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion

placebodrug

placebo administered on Day 1 as a single intravenous infusion