Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Evidence for vasospasm or DCI prior to study enrollment
Hemodynamically unstable pre-enrollment
Severe or unstable concomitant condition or disease (e.g., known significant neurological deficit, cancer, hematologic or coronary disease), or chronic condition (e.g., liver disease, kidney disease, or psychiatric disorder), that may increase the risk associated with study participation, or may interfere with the interpretation of study results
Subjects who have received an investigational product or participated in another interventional clinical study within 30 days prior to enrollment.
Trial design
Treatments tested in this trial
- tocilizumab-aazg (TYENNE)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov