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

Description

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.

Conditions

Sickle Cell Disease

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Study Overview

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Study Details

Study overview

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.

An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

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

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University Of Alabama, Birmingham, Alabama, United States, 35233

Washington

Childrens National Hospital, Washington, District of Columbia, United States, 20010

Augusta

Augusta University Georgia Patient Treatment, Augusta, Georgia, United States, 30912

Greenville

East Carolina University SC, Greenville, North Carolina, United States, 27834

Greenville

East Carolina University East Carolina University, Greenville, North Carolina, United States, 27858

Philadelphia

Childrens Hospital Of Philadelphia Patient Treatment, Philadelphia, Pennsylvania, United States, 19104-4399

Fort Worth

Cook Childrens Medical Center, Fort Worth, Texas, United States, 76104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

6 Months to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2031-10-27