THRIVE: Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events
University of Florida
Summary
In this study, tocilizumab-aazg (TYENNE) will be administered to see whether tocilizumab-aazg is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.
Description
This is a prospective single-arm, single-center, open-label Phase 1 trial of tocilizumab-aazg 6mg/kg IV infusion drip on Day 0 in patients with aneurysmal subarachnoid hemorrhage. The trial is designed to demonstrate safety and to detect a signal that tocilizumab-aazg prevents delayed cerebral ischemia in these patients.
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult patients (aged ≥18 years) with Hunt Hess Grade 1-3, Fisher score 3 or 3 and 4, aneurysmal subarachnoid hemorrhage within 24 hours of symptom onset (ruptured aneurysm confirmed by CTA, MRA or DSA) * Must have external ventricular drain or lumbar drain, or plan to place an external ventricular drain or lumbar drain. * Female subjects of child-bearing potential must have negative pregnancy test * Signed informed consent from subject or legally authorized representative * Able and willing to comply with followup visits * For women of childbearing potential: agreement t…
Interventions
- Drugtocilizumab-aazg (TYENNE)
A single dose of tocilizumab-aazg (TYENNE) will be administered by intravenous drip.
Location
- University of Florida Health (UF Health)Gainesville, Florida