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Monoclonal Antibodies
Satralizumab for Brain Aneurysm (SASH Trial)
Phase < 1
Waitlist Available
Led By Brian Hoh, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if satralizumab is safe and effective in preventing strokes after a brain aneurysm.
Who is the study for?
Adults aged ≥18 with a recent (within 72 hours) burst brain aneurysm, graded Hunt Hess 1-3 and Fisher score 3, who have had the ruptured aneurysm secured. They must be able to follow up visits, not pregnant or breastfeeding, agree to contraception if applicable, and have no severe health issues that could interfere with the trial.
What is being tested?
The safety of satralizumab for patients with a burst brain aneurysm is being tested in this study. Researchers want to see if it can prevent further strokes in these patients by administering satralizumab after the initial event.
What are the potential side effects?
Potential side effects of satralizumab may include allergic reactions like rash or swelling, infections due to immune system suppression, liver function changes, blood cell count alterations which might lead to bleeding or infection risk increase.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of death
Frequency of observed and reported adverse events
Number of participants with decreased platelet count
+2 moreSide effects data
From 2021 Phase 3 trial • 85 Patients • NCT02028884100%
Ear infection
100%
Lymphocyte percentage increased
100%
Rash
100%
Haemorrhoids
100%
White blood cell count decreased
100%
Rhinitis
100%
Localised infection
100%
Hypotension
100%
Lymphocyte percentage decreased
100%
Oropharyngeal pain
100%
Neutrophil percentage increased
100%
Platelet count increased
100%
Monocyte count increased
100%
White blood cell count increased
100%
Pruritus
100%
Headache
100%
Diarrhoea
100%
Abdominal pain
100%
Tonsillitis
100%
Dysmenorrhoea
100%
Rectal haemorrhage
100%
Neutrophil count increased
100%
Haemoglobin decreased
100%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Baseline Treatment Open Label Period
Satralizumab Open-Label Period
Satralizumab + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Double Blind Period
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SatralizumabExperimental Treatment1 Intervention
Subjects will receive satralizumab 120mg subcutaneous Day 0 and Day 14 after enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,223 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,000 Total Patients Enrolled
Brian Hoh, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active lung condition that affects the tissue and space around the air sacs.I haven't had any live vaccines in the last 6 weeks.I haven't taken anti-CD4, cladribine, or mitoxantrone in the last 2 years.I haven't taken specific immune system affecting drugs in the last 6 months.I have not had any cancer except for certain skin cancers or treated cervical cancer in the last 5 years.I haven't had treatments like IL-6 inhibitors, alemtuzumab, total body irradiation, or bone marrow transplant in the last 6 months.I have not had any serious infections in the last 4 weeks.I do not have any other nerve damage diseases or PML.I have a history of diverticulitis that might increase my risk of serious gut issues.I have not had any major surgery in the last 4 weeks.I have not had serious infections like pneumonia or sepsis before joining.I have not had thoughts of suicide in the last 6 months or attempted suicide in the last 3 years.I do not have active or untreated latent tuberculosis.I have had a serious infection treated with antibiotics before screening.I am an adult with a mild to moderate brain hemorrhage from a ruptured aneurysm, confirmed by a scan within the last 72 hours.I agree to use birth control during the study.I have difficulty with blood draws or IV insertions due to poor vein access.I am a woman who can have children and my pregnancy test is negative.I do not have any severe health conditions that could worsen by joining this study.I do not have chronic hepatitis B or C, nor am I HIV positive.I do not have any severe uncontrolled diseases that could stop me from joining the trial.My ruptured aneurysm has been successfully treated with surgery or a minimally invasive procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Satralizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.