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

NCT03963895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-07

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Aronora, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-03
Primary Completion
2020-12-29
Completion
2020-12-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963895 on ClinicalTrials.gov