THRIVE
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StatusAccepting Candidates
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Age18 Years - 89 Years
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SexesAll
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Healthy VolunteersNo
Objective
In this study, satralizumab will be administered to see whether satralizumab is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.
Description
SASH is a prospective single-arm, single-center, open-label Phase 1 trial of satralizumab 120mg subcutaneous Day 0 and Day 14 in subjects with Hunt Hess grade 1-3, Fisher score 3 aneurysmal subarachnoid hemorrhage and an external ventricular drain or lumbar drain. The trial is designed to demonstrate safety and to detect a signal that satralizumab prevents delayed cerebral ischemia in these patients.
Details
| Full study title | THRIVE: Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events |
| Protocol number | OCR43615 |
| ClinicalTrials.gov ID | NCT05727657 |
| Phase | Early Phase 1 |
Eligibility
Inclusion Criteria:
Adult patients (aged ≥18 years) with Hunt Hess Grade 1-3, Fisher score 3 or 3 and 4, aneurysmal subarachnoid hemorrhage within 72 hours of symptom onset (ruptured aneurysm confirmed by CTA, MRA or DSA)
Must have surgical or endovascular adequate occlusion of the ruptured aneurysm
Must have 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
Women and males of childbearing potential must agree to appropriate methods of contraception during study participation
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 to satralizumab and/or other biologics agents
Serious infection defined as pneumonia, sepsis/septic shock, and neutropenic fever prior to enrollment
Any previous treatment with IL-6 inhibitory therapy (e.g. tocilizumab), alemtuzumab, 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 3 months after the final dose of satralizumab
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 other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
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 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 completely excised and cured).
Laboratory exclusion criteria (at screening):
White blood cells (WBC)
Lead researcher
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Brian L Hoh, MD, MBA, FACS, FAHA, FAANSNeurosurgeon, Neurovascular Surgeon
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.