Crizanlizumab for Anemia, Sickle Cell

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Anemia, Sickle Cell+1 More
Crizanlizumab - Drug
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

3 of 3
This is further along than 93% of similar trials

Other trials for Anemia, Sickle Cell

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

3 of 3
This is further along than 85% of similar trials

Other trials for Anemia, Sickle Cell

Side Effects for

Crizanlizumab
8%Chest pain
4%Dark and Infrequent Urination
4%Venous thrombembolism
4%Diarrhea
4%Altered mental status
4%Headache
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT04435184) in the Crizanlizumab ARM group. Side effects include: Chest pain with 8%, Dark and Infrequent Urination with 4%, Venous thrombembolism with 4%, Diarrhea with 4%, Altered mental status with 4%.

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: Drug
Treatment
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 preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

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.