Your session is about to expire
← Back to Search
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
SASH Trial 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.Check my eligibility
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.See study design
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.
SASH Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0202888421%
Upper respiratory tract infection
18%
Nasopharyngitis
15%
Headache
13%
Anaemia
13%
Urinary tract infection
13%
Alanine aminotransferase increased
11%
Alopecia
11%
Hyperlipidaemia
11%
Vertigo
11%
Chest discomfort
11%
Complement factor decreased
11%
Conjunctivitis
10%
Leukopenia
10%
Lymphopenia
8%
Conjunctival haemorrhage
8%
Diarrhoea
8%
Arthralgia
8%
Oral herpes
8%
Cough
8%
Eczema
6%
Oral candidiasis
6%
Bradycardia
6%
Hypertransaminasaemia
6%
Retinal haemorrhage
6%
Hypofibrinogenaemia
6%
Left ventricle outflow tract obstruction
6%
Blepharospasm
6%
Conjunctival deposit
6%
Dry eye
6%
Glaucoma
6%
Excoriation
6%
Blood urine
6%
Protein urine present
6%
Dehydration
6%
Amenorrhoea
6%
Pharyngeal erythema
6%
Acne
6%
Intervertebral disc protrusion
6%
Muscle spasticity
6%
Blood alkaline phosphatase increased
6%
Polycythaemia
6%
Oedema peripheral
6%
Bacteriuria
6%
Pyelonephritis
6%
Respiratory tract infection
6%
Wound
6%
Epistaxis
6%
Musculoskeletal stiffness
6%
Large intestine polyp
6%
Pancreatitis acute
6%
Feeling abnormal
6%
Hepatic function abnormal
6%
Arthropod sting
6%
Feeling hot
6%
Pelvic fracture
6%
Osteoarthritis
6%
Nephrolithiasis
6%
Platelet count decreased
6%
Cataract
6%
Chills
6%
Contusion
6%
Serum ferritin decreased
6%
Dyspepsia
6%
Onychomycosis
6%
Viral upper respiratory tract infection
6%
Upper respiratory tract inflammation
6%
Plicated tongue
6%
Compression fracture
6%
Urobilinogen urine increased
6%
Neck pain
6%
Malaise
6%
Angina pectoris
6%
Abdominal distension
6%
Cellulitis
6%
Enterocolitis infectious
6%
Pneumonia
6%
Joint injury
6%
Weight increased
6%
Myopathy toxic
6%
Spinal osteoarthritis
6%
Epilepsy
6%
Lower limb fracture
6%
Low density lipoprotein increased
6%
Weight decreased
6%
Iron deficiency
6%
Erythema
6%
Rash pruritic
6%
Spinal pain
6%
Intercostal neuralgia
6%
Eye pruritus
6%
Panic disorder
5%
Pain in extremity
5%
Ear discomfort
5%
Neutropenia
5%
Bronchitis
5%
Rib fracture
5%
Constipation
5%
Gastritis
5%
Fall
5%
Cystitis
5%
Blepharitis
5%
Hypocomplementaemia
5%
Laryngitis
5%
Oropharyngeal pain
5%
Dental caries
5%
Sinusitis
5%
Thermal burn
5%
Dyslipidaemia
5%
Hypercholesterolaemia
5%
Myalgia
5%
Anxiety
5%
Flushing
5%
Hypertension
5%
Blood fibrinogen decreased
5%
Blood fibrinogen increased
5%
Blood pressure increased
5%
Prothrombin time prolonged
5%
Rhinorrhoea
5%
Rash
5%
Muscle spasms
3%
Lymphocyte percentage increased
3%
Cervical dysplasia
3%
Gait disturbance
3%
Vomiting
3%
Influenza
3%
Upper limb fracture
3%
Tonsillitis
3%
Haemoglobin decreased
3%
Toothache
3%
Pharyngitis
3%
Dizziness
3%
Hordeolum
3%
Haemorrhoids
3%
Insomnia
3%
Periodontitis
3%
Neutrophil count decreased
3%
White blood cell count decreased
3%
Back pain
3%
Parkinsonism
3%
White blood cell count increased
3%
Hepatitis E
3%
Spinal compression fracture
3%
Large intestine infection
3%
Forearm fracture
3%
Lumbar spinal stenosis
3%
Neuromyelitis optica pseudo relapse
3%
Iron deficiency anaemia
3%
Abdominal pain upper
3%
Rhinitis
3%
Aspartate aminotransferase increased
3%
Urticaria
3%
Blood creatine phosphokinase increased
3%
Lymphocyte count decreased
3%
Non-cardiac chest pain
3%
Neutrophil count increased
3%
Neutrophil percentage increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Baseline Treatment Double Blind Period
Satralizumab + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Open Label Period
Satralizumab Open-Label Period
SASH 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
~180
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,342 Previous Clinical Trials
715,658 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,076 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor open to individuals aged 25 or older?
"Following the guidelines of this clinical trial, potential participants must be 18 years old and younger than 89."
Answered by AI
Is it possible for me to join this research endeavor?
"This trial seeks to enrol qualifying individuals with brain aneurysms, aged between 18 and 89. Currently, 15 patients are being sought after for the clinical study."
Answered by AI
Is this research project still accepting participants?
"As indicated on clinicaltrials.gov, this trial has finished its recruitment process and is no longer accepting patients at this time. The study was first posted July 1st 2023 and last modified February 13th 2023. Despite the closure of this particular medical research, there are 774 other trials currently recruiting participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger