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Safety Evaluation of 3K3A-APC in Ischemic Stroke

NCT02222714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-11-08

Study results available
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Summary

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

Conditions

Interventions

BIOLOGICAL

3K3A-APC

3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion

DRUG

Placebo

Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Iowa

    collaborator OTHER

  • ZZ Biotech, LLC

    lead INDUSTRY

Principal Investigators

  • Patrick D. Lyden, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-04-18
Completion
2017-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02222714 on ClinicalTrials.gov