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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

CRIZ Trial 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.

CRIZ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sickle cell disease with a confirmed specific genotype.
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I've had 2 to 10 pain crises due to sickle cell disease in the last year.
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I am 16 years old or older.
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My blood counts are within normal ranges.
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I agree not to get pregnant and to use birth control while taking crizanlizumab and for 3 months after.

CRIZ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

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 • NCT04435184
8%
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

CRIZ 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
2,855 Previous Clinical Trials
4,197,322 Total Patients Enrolled
Andria FordLead Sponsor

Media Library

Crizanlizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05334576 — N/A
Sickle Cell Disease Research Study Groups: Single Arm: Crizanlizumab
Sickle Cell Disease Clinical Trial 2023: Crizanlizumab Highlights & Side Effects. Trial Name: NCT05334576 — N/A
Crizanlizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05334576 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any open recruitment opportunities for this clinical trial?

"According to the data hosted on ClinicalTrials.gov, this clinical trial is actively recruiting participants after having been initially posted and recently updated both on April 11th 2022."

Answered by AI

How many participants are being accepted to join this research project?

"Affirmative, clinicaltrials.gov data verifies that the trial has been active since its posting on April 11th 2022 and is actively seeking enrolment from 31 individuals at 1 medical centre."

Answered by AI
~3 spots leftby Jul 2024