Actively Recruiting
THRIVE: 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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating tocilizumab-aazg (TYENNE) for patients who have had a burst brain aneurysm, known as aneurysmal subarachnoid hemorrhage. The study aims to assess the safety of this medication and to explore whether it might help prevent strokes caused by delayed cerebral ischemia in these patients. This is an open-label Phase 1 trial conducted at a single center. Participants will receive a single intravenous infusion of tocilizumab-aazg at a dose of 6 mg per kilogram of body weight on Day 0 after their aneurysmal hemorrhage and enrollment. The trial involves no placebo or comparison group, focusing on monitoring effects after this infusion. The treatment is designed to be given shortly after symptom onset, within 24 hours. During the study, participants will be closely monitored for safety and potential side effects up to 90 days after the infusion. Researchers will track liver enzyme levels, blood cell counts, adverse events, and mortality rates. Participants will also have to comply with follow-up visits and undergo laboratory tests and clinical evaluations to assess their condition and response to the treatment throughout the trial period.
CONDITIONS
Brief 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
- Diagnosis of aneurysmal subarachnoid hemorrhage within 24 hours of symptom onset confirmed by CTA, MRA, or DSA
- Must have or plan to have an external ventricular drain or lumbar drain
- Female subjects of child-bearing potential must have a negative pregnancy test
- Signed informed consent from the patient or legally authorized representative
- Able and willing to comply with follow-up visits
- Women of childbearing potential must agree to remain abstinent or use specified non-hormonal contraceptive methods 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
You will not qualify if you...
- Evidence of vasospasm or delayed cerebral ischemia before enrollment
- Hemodynamically unstable before enrollment
- Severe or unstable medical conditions or chronic diseases that increase risk or interfere with study results
- Participation in another interventional clinical trial or investigational product use within 30 days before enrollment
- Known severe allergic reaction to tocilizumab or similar biologics
- Serious infections such as pneumonia, sepsis, or neutropenic fever before enrollment
- Previous treatment with IL-6 inhibitory therapy or certain immunomodulatory drugs within specified timeframes
- Pregnant or breastfeeding, or intending pregnancy during the study or 2 months after dosing
- Surgical procedures (except minor) within 4 weeks prior to baseline
- Serious uncontrolled diseases affecting various organ systems
- Active infections or history of diverticulitis increasing complication risks
- Evidence of active or untreated latent tuberculosis
- Receipt of live vaccines within 6 weeks before baseline and during study
- History of malignancy within last 5 years except certain skin or cervical cancers
- Laboratory exclusions including low white blood cells, neutrophils, lymphocytes, platelets, or elevated liver enzymes
- Known chronic active hepatitis B or C, positive hepatitis or HIV tests
- Illicit drug or alcohol abuse within 12 months prior to screening
- Poor venous access
- Abnormal ECG with significant findings as judged by investigator
- Any serious medical condition or lab abnormality precluding safe participation or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 21 days
Participants receive a single intravenous infusion of tocilizumab-aazg (TYENNE) on Day 0 following subarachnoid hemorrhage and enrollment in the trial.
1 infusion visit and follow-up assessments up to 21 days
Duration - Up to 90 days following treatment
Participants are monitored for safety and adverse events including liver function, blood counts, and overall health for up to 90 days after treatment.
Multiple follow-up visits over 90 days
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here