Actively Recruiting
Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events
Led by University of Florida · Updated on 2026-03-04
30
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older with Hunt Hess Grade 1-3 and Fisher score 3 or 3 and 4
- Aneurysmal subarachnoid hemorrhage within 24 hours of symptom onset confirmed by CTA, MRA or DSA
- Must have or plan to place an external ventricular drain or lumbar drain
- Female participants of child-bearing potential must have a negative pregnancy test
- Signed informed consent from the participant or legally authorized representative
- Able and willing to comply with follow-up visits
- Women of childbearing potential must agree to remain abstinent or use reliable non-hormonal contraception during treatment and for 2 months after final dose
- Men must agree to remain abstinent or use a condom during treatment and for 2 months after dosing, and refrain from donating sperm during this time
You will not qualify if you...
- Evidence of vasospasm or delayed cerebral ischemia before enrollment
- Hemodynamically unstable before enrollment
- Severe or unstable other diseases or conditions that increase risk or interfere with study results
- Participation in another interventional clinical study within 30 days prior to enrollment
- Known hypersensitivity or severe allergic reaction to tocilizumab or similar biologics
- Serious infections including pneumonia, sepsis, or neutropenic fever before enrollment
- Previous treatment with IL-6 inhibitors or certain immune therapies within specified timeframes
- Pregnancy, breastfeeding, or planning pregnancy during study or within 2 months after dosing
- Recent major surgery within 4 weeks prior to baseline
- Serious uncontrolled diseases like nervous system, cardiovascular, respiratory, immune, or others
- Active infections or tuberculosis within 4 weeks prior to baseline
- History of diverticulitis with risk of complications
- Receipt of live vaccines within 6 weeks prior to baseline and during study
- History of malignancy within last 5 years except certain skin or cervical cancers
- Laboratory abnormalities including low white blood cells, neutrophils, lymphocytes, platelets, or elevated liver enzymes
- Known chronic active hepatitis B or C, HIV infection
- Illicit drug or alcohol abuse within 12 months prior to screening
- Poor peripheral venous access
- Serious infections requiring antibiotics prior to screening
- Clinically significant abnormal ECG findings including certain heart blocks or prior heart attack
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida Health (UF Health)
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
B
Brian Hoh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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