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Clinical Trials in the USA / NCT04657822
Recruiting Phase 4

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

NCT04657822 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2021-06-10
Last updated
2026-06-08

Condition(s) studied

Sickle Cell Disease

Investigational drug(s) / intervention(s)

Crizanlizumab

Crizanlizumab: Concentrate for solution for infusion for Intravenous use

Study summary

This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

Eligibility

Sex
ALL
Min age
6 Months
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent/assent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by the patient and/or by the parents or legal guardian prior to enrolling in the rollover study and receiving study medication 2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study. Patient is currently benefiting from the treatment with crizanlizumab as determined by the investigator and has completed the treatment schedule as planned in the parent study 3. Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules Exclusion Criteria: 1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion 2. Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved unless those toxicities were grade 4 3. Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial 4. Pregnant or nursing women 5. Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab 6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
University Of Alabama Birmingham Alabama Recruiting
Childrens National Hospital Washington D.C. District of Columbia Active Not Recruiting
Augusta University Georgia Augusta Georgia Recruiting
East Carolina University Greenville North Carolina Completed
East Carolina University Greenville North Carolina Completed
Childrens Hospital of Philadelphia Philadelphia Pennsylvania Active Not Recruiting
Cook Childrens Medical Center Fort Worth Texas Completed
Novartis Investigative Site Brussels Belgium Completed
Novartis Investigative Site Laken Belgium Active Not Recruiting
Novartis Investigative Site Liège Belgium Active Not Recruiting
Novartis Investigative Site Salvador Estado de Bahia Active Not Recruiting
Novartis Investigative Site Ribeirão Preto São Paulo Active Not Recruiting
Novartis Investigative Site São Paulo São Paulo Active Not Recruiting
Novartis Investigative Site Barranquilla Atlántico Recruiting
Novartis Investigative Site Valledupar Cesar Department Recruiting
Novartis Investigative Site Cali Valle del Cauca Department Active Not Recruiting
Novartis Investigative Site Montería Colombia Active Not Recruiting
Novartis Investigative Site Créteil France Completed
Novartis Investigative Site Paris France Active Not Recruiting
Novartis Investigative Site Paris France Completed
Novartis Investigative Site Heidelberg Germany Active Not Recruiting
Novartis Investigative Site Padova PD Active Not Recruiting
Novartis Investigative Site Orbassano TO Completed
Novartis Investigative Site Beirut Lebanon Recruiting
Novartis Investigative Site Tripoli Lebanon Recruiting
Novartis Investigative Site Khoudh Oman Recruiting
Novartis Investigative Site Barcelona Spain Completed
Novartis Investigative Site Madrid Spain Active Not Recruiting
Novartis Investigative Site Hatay Antakya Withdrawn
Novartis Investigative Site Adana Saricam Active Not Recruiting
Novartis Investigative Site Adana Yuregir Active Not Recruiting

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04657822 on ClinicalTrials.gov ↗ ← All trials in the USA