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โ† Trials
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Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events

RecruitingPhase 1Ages 18 Years - 89 YearsAllUniversity of Florida
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult patients (aged โ‰ฅ18 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 to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of 1% per year during the treatment period and for 2 months after the final dose of TYENNE. Women must refrain from donating or storing eggs during the same time period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mรผllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. The following are examples of adequate non-hormonal contraceptive methods: bilateral tubal ligation; male sterilization; copper intrauterine devices; male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide. โ€ข For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 2 months after the dose of TYENNE to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the local Informed Consent Form. Exclusion Criteria: * 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. * Known hypersensitivity or severe allergic reaction to tocilizumab and/or other biologics agents (i.e. shock, anaphylactic reactions) * Serious infection defined as pneumonia, sepsis/septic shock, and neutropenic fever prior to enrollment * Any previous treatment with IL-6 inhibitory therapy (e.g. satralizumab), alemtuzumab, etc. * Total body irradiation or bone marrow transplantation within 6 months prior to baseline. * Any previous treatment with anti-CD20, anti-CD19, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline. * Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline * Pregnant or breastfeeding, or intending to become pregnant during the study or within 2 months after TYENNE administration * Women of childbearing potential must have a negative serum pregnancy test result prior to initiation of study drug. * Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline. * Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency. * Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline. * History of diverticulitis that, in the principal investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation. * Evidence of active or untreated latent tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection). * Evidence of active interstitial lung disease * Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline and throughout the duration of the study. * History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been complet
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What it tests

  • tocilizumab-aazg (TYENNE)
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Where

1 site
University of Florida Health (UF Health)
Gainesville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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