Aneurysmal Subarachnoid HemorrhageEarly Phase 1SASHNCT05727657
Satralizumab in Aneurysmal Subarachnoid Hemorrhage
A Early Phase 1 study testing Satralizumab in people with Aneurysmal Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia
- What is being tested?
- Satralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to 24 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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) <3.0 x103/μL
- Absolute neutrophil count (ANC) <2.0 x103/μL
- Absolute lymphocyte count <0.5 x103/μL
- Platelet count <10 x 104/μL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN).
- Patient with known medical history at screening listed for the following must be excluded from this trial:
- Evidence of chronic active hepatitis B (HBV)
- Evidence of chronic active hepatitis C (HCV)
- Positive for hepatitis C virus (HCV) antigen
- Positive for hepatitis B surface antigen (HBsAg)
- Known HIV infection.
- Viral antigen tests for HBV, HCV and HIV to be performed on Day 0 (day of first dose of satralizumab). If the result of HBV, HCV, or HIV comes back positive the 2nd dose of satralizumab (Day 14) will not be administered
- Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
- Poor peripheral venous access
- Serious infection requiring oral or IV antibiotics prior to screening
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree atrioventricular heart block, or evidence of prior myocardial infarction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida (UF) Health Shands Hospital
Gainesville, Florida, 32608
About this study
Official title: A Phase 1 Clinical Trial of Satralizumab as a Treatment for Aneurysmal Subarachnoid Hemorrhage
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.
Read the detailed 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.
- Being tested
- Satralizumab
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SatralizumabDrug
120mg subcutaneous Day 0 and Day 14
| Study group | Role | What they receive |
|---|---|---|
| Satralizumab | Experimental | Subjects will receive satralizumab 120mg subcutaneous Day 0 and Day 14 after enrollment. Receives: Drug: Satralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with elevation of liver transaminases
Elevation of liver transaminase (ALT, AST) is defined as >5x upper limit of normal.
Measured: baseline up to 21 days
Number of participants with neutropenia
Neutropenia is defined as neutrophil count below 1 x 10^9/L.
Measured: baseline up to 21 days
Number of participants with decreased platelet count
Decreased platelet count is defined as a platelet count below the lower institutional limit of normal.
Measured: baseline up to 21 days
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.
Measured: baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
Frequency of death
All deaths that occur during the protocol-specified AE reporting period, regardless of attribution, will be recorded.
Measured: baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study startJun 2024 (estimated)
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: Lost support from the drug manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian Hoh, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727657
- Sponsor's protocol ID
- OCR43615
- Acronym
- SASH
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial of Satralizumab as a Treatment for Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT05727657
- Acronym / sponsor ID
- SASH / OCR43615
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lost support from the drug manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2024 (estimated)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Satralizumab | Experimental | Drug: SatralizumabSubjects will receive satralizumab 120mg subcutaneous Day 0 and Day 14 after enrollment. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Satralizumab120mg subcutaneous Day 0 and Day 14 | Drug | Satralizumab |
Primary outcome
Number of participants with elevation of liver transaminases
Time frame: baseline up to 21 days
Elevation of liver transaminase (ALT, AST) is defined as >5x upper limit of normal.
Number of participants with neutropenia
Time frame: baseline up to 21 days
Neutropenia is defined as neutrophil count below 1 x 10^9/L.
Number of participants with decreased platelet count
Time frame: baseline up to 21 days
Decreased platelet count is defined as a platelet count below the lower institutional limit of normal.
Frequency of observed and reported adverse events
Time frame: baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
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.
Frequency of death
Time frame: baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
All deaths that occur during the protocol-specified AE reporting period, regardless of attribution, will be recorded.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Hoh, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Satralizumab in people with Aneurysmal Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with elevation of liver transaminases (time frame: baseline up to 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.