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Monoclonal Antibodies
Crizanlizumab for Sickle Cell Disease (CRIZ Trial)
N/A
Recruiting
Research Sponsored by Andria Ford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype
Increased severity of sickle cell disease including having between 2 and 10 sickle cell-related pain crises within the preceding 12 months
Must not have
Inability to return for follow-up
Current chronic transfusion therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Summary
This trial will test whether the drug crizanlizumab can prevent the progression of silent cerebral infarcts in patients with sickle cell disease.
Who is the study for?
This trial is for individuals with sickle cell disease at risk of silent cerebral infarcts. They should have had multiple pain crises in the past year and be over 16 years old. Participants must not be on chronic transfusion therapy, planning major treatments like stem cell transplants, or have used investigational drugs recently. Women who can bear children must use contraception and avoid pregnancy during and after the study.Check my eligibility
What is being tested?
The study is testing Crizanlizumab's effectiveness in preventing silent brain injuries in sickle cell patients by comparing brain MRIs before treatment and at two intervals (6 and 30 months) after starting Crizanlizumab infusions against a group not receiving it.See study design
What are the potential side effects?
Potential side effects of Crizanlizumab may include allergic reactions to the drug, increased risk of infections due to immune system suppression, liver issues reflected by abnormal blood tests, or other infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have sickle cell disease with a confirmed specific genotype.
Select...
I've had 2 to 10 pain crises due to sickle cell disease in the last year.
Select...
My blood counts are within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot come back for follow-up visits.
Select...
I am currently on a long-term blood transfusion plan.
Select...
I currently have an acute infection.
Select...
I am planning to undergo a bone marrow transplant or a brain blood vessel surgery.
Select...
I have HIV, untreated TB, active hepatitis B or C, or shingles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
New or enlarged silent cerebral infarcts
Secondary outcome measures
Infarct Progression
Side effects data
From 2021 Phase 2 trial • 54 Patients • NCT044351848%
Chest pain
4%
Headache
4%
Diarrhea
4%
Dark and Infrequent Urination
4%
Venous thrombembolism
4%
Altered mental status
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crizanlizumab
Placebo Saline
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm: CrizanlizumabExperimental Treatment1 Intervention
Single-arm: Patients with sickle cell disease and increased risk of silent cerebral infarcts
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,874 Previous Clinical Trials
4,199,960 Total Patients Enrolled
Andria FordLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot come back for follow-up visits.I am currently on a long-term blood transfusion plan.I currently have an acute infection.Your doctor thinks you have a high chance of having silent strokes in your brain based on certain criteria.You are allergic to any of the drugs being used in the study.I am planning to undergo a bone marrow transplant or a brain blood vessel surgery.Your liver function tests show levels more than 3 times the normal range.I have sickle cell disease with a confirmed specific genotype.I have taken blood thinners in the last 30 days.You cannot have an MRI for medical reasons.I have HIV, untreated TB, active hepatitis B or C, or shingles.You have a history of medical, neurological, social, or substance abuse issues that could affect the results of a brain MRI in the future.I've had 2 to 10 pain crises due to sickle cell disease in the last year.I am 16 years old or older.Your test results show a higher chance of risk for the study.My blood counts are within normal ranges.I agree not to get pregnant and to use birth control while taking crizanlizumab and for 3 months after.I haven't taken any monoclonal antibody medications in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm: Crizanlizumab
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.
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