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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
tocilizumab-aazg (TYENNE)
DrugA single dose of tocilizumab-aazg (TYENNE) will be administered by intravenous drip.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: tocilizumab-aazg (TYENNE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with elevation of liver transaminases
Elevation of liver transaminase (ALT, AST) is defined as \>5x upper limit of normal.
Time frame
up to 21 days2
Number of participants with neutropenia
Neutropenia is defined as neutrophil count below 1 x 10\^9/L.
Time frame
up to 21 days3
Number of participants with decreased platelet count
Decreased platelet count is defined as a platelet count below the lower institutional limit of normal.
Time frame
up to 21 days4
Frequency of observed and reported adverse events
An adverse event will be defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.
Time frame
baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlierSponsors and contacts
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Source ClinicalTrials.gov