Crizanlizumab for Anemia, Sickle Cell
Phase-Based Progress Estimates
Effectiveness
Safety
Anemia, Sickle Cell+1 More
Crizanlizumab - DrugEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
This trial will allow continued access to the drug crizanlizumab for patients with sickle cell disease who are benefiting from the treatment.
Eligible Conditions
- Anemia, Sickle Cell
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: from day of first dose of study medication to 105 days after last dose of study medication
Not Applicable - Study Completion
Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study
Day 105
Number of participants with treatment emergent adverse events
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Crizanlizumab
8%Chest pain
4%Dark and Infrequent Urination
4%Venous thrombembolism
4%Diarrhea
4%Altered mental status
4%Headache
Trial Design
1 Treatment Group
Crizanlizumab
1 of 1
Experimental Treatment
130 Total Participants · 1 Treatment Group
Primary Treatment: Crizanlizumab · No Placebo Group · Phase 4
Crizanlizumab
Drug
Experimental Group · 1 Intervention: Crizanlizumab · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizanlizumab
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from day of first dose of study medication to 105 days after last dose of study medication
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,692 Previous Clinical Trials
3,522,909 Total Patients Enrolled
18 Trials studying Anemia, Sickle Cell
4,181 Patients Enrolled for Anemia, Sickle Cell
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:According to local guidelines, written informed consent/assent must be signed by adult patients
The patient is currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study
The patient has complied with the planned visit schedule in the parent study, and the investigator believes that the patient is willing and able to comply with future visit schedules.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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