Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke

NCT05484154 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: ZZ-3K3A-301UG3NS119199
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Stroke; APC; 3K3A; 3K3A-APC; Activated protein C; RHAPSODY

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of 3K3A-APC on 90-day disability

  Day 90 mRS scores will be compared between groups using ordinal (shift) analysis

  Day 90 mRS

Secondary Outcomes (1)

• To evaluate the safety of 3K3A-APC

  Baseline to Day 90

Study Arms (4)

10mg of 3K3A-APC

ACTIVE COMPARATOR

3K3A-APC, q12h for up to 5 doses

Biological: 3K3A-APC

15mg of 3K3A-APC

ACTIVE COMPARATOR

3K3A-APC, q12h for up to 5 doses

Biological: 3K3A-APC

30mg of 3K3A-APC

ACTIVE COMPARATOR

3K3A-APC, q12h for up to 5 doses

Biological: 3K3A-APC

Placebo

PLACEBO COMPARATOR

Matching placebo, q12h for up to 5 doses

Other: Placebo

Interventions

3K3A-APC BIOLOGICAL

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

Also known as: 3K3A-Activated Protein C

10mg of 3K3A-APC; 15mg of 3K3A-APC; 30mg of 3K3A-APC

Placebo OTHER

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

Also known as: Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke
• Able to receive thrombolysis, mechanical thrombectomy or both
• National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5
• Signed informed consent
• Agreement to use effective birth control throughout the study

You may not qualify if:

• Neurologic deficit is non-disabling
• History of stroke or penetrating head injury within 90 days prior to enrollment
• History of previous or current diagnosis of intracranial hemorrhage
• Moyamoya disease, cerebral arteriovenous malformation, or known unsecured aneurysm requiring intervention during the acute study period
• Presence of tandem lesions suggesting a likely need for proximal artery stenting during the thrombectomy procedure that would mandate post-operative dual antiplatelet therapy
• Presence of other neurological or non-neurological co-morbidities, independently of the current stroke, that may lead to further deterioration in the subject's neurological status during the study period
• Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)
• Severe hypertension or hypotension
• Blood glucose concentration \< 50 mg/dL
• Prior exposure to any exogenous form of a recombinant variant of human APC

Sponsors & Collaborators

• ZZ Biotech, LLC: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Southern California: collaborator
• University of Cincinnati: collaborator
• University of South Carolina: collaborator

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

3K3A-APC protein

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrick D Lyden, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share