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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04657822
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Crizanlizumab Phase 4

Detailed Description:

There will be no screening period for this study as patients will transfer directly from parent studies. After providing informed consent, all eligible participants should start Crizanlizumab treatment at the earliest convenience following the treatment schedule of 28 days of the last dose in the parent study. Crizanlizumab will be administered at the same dose/schedule as in the parent study.

Study participants will have a safety follow up visit conducted 105 days after last administration of study treatment. The safety follow up at 105 days is not applicable for those participants who continue to receive Crizanlizumab after end of treatment visit either commercially or through PSDS.

The study is expected to remain open for 10 years from the first Patient's first visit (FPFV) in this clinical study or until study treatment becomes commercially available and is reimbursed in the respective indication or until such time that all enrolled patients no longer need treatment with Crizanlizumab, or a PSDS treatment plan is allowed and approved as per local laws and regulations, whichever comes first

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : October 27, 2031
Estimated Study Completion Date : October 27, 2031

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crizanlizumab
All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.
Drug: Crizanlizumab
Concentrate for solution for infusion for Intravenous use
Other Name: SEG101




Primary Outcome Measures :
  1. 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 [ Time Frame: Not Applicable - Study Completion ]
    Protocol to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study, benefited from the treatment and do not have access to reimbursed, commercially available crizanlizumab.


Secondary Outcome Measures :
  1. Number of participants with treatment emergent adverse events [ Time Frame: from day of first dose of study medication to 105 days after last dose of study medication ]
    The number of participants with Frequency, severity and causality of treatment emergent adverse events will be collected.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657822


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Alabama
Novartis Investigative Site Recruiting
Birmingham, Alabama, United States, 35233
Contact: Christy Patrick    205-638-2792    cpatrick@uabmc.edu   
Principal Investigator: Thomas Howard         
United States, North Carolina
Novartis Investigative Site Recruiting
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104-4399
Contact    267-426-9338      
Principal Investigator: Helge D Hartung         
United States, Texas
Novartis Investigative Site Recruiting
Fort Worth, Texas, United States, 76104
Contact: Patty Penn       Patty.Penn2@cookchildrens.org   
Principal Investigator: Clarissa Johnson         
Belgium
Novartis Investigative Site Recruiting
Brussel, Belgium, 1000
Novartis Investigative Site Recruiting
Laeken, Belgium, 1020
Novartis Investigative Site Recruiting
Liege, Belgium, 4000
Brazil
Novartis Investigative Site Recruiting
Salvador, BA, Brazil, 41253-190
Novartis Investigative Site Recruiting
Ribeirao Preto, SP, Brazil, 14051-140
Novartis Investigative Site Recruiting
São Paulo, SP, Brazil, 01232-010
Colombia
Novartis Investigative Site Recruiting
Cali, Valle Del Cauca, Colombia
France
Novartis Investigative Site Recruiting
Paris, France, 75015
Germany
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Italy
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Recruiting
Orbassano, TO, Italy, 10043
Lebanon
Novartis Investigative Site Recruiting
Beirut, Lebanon, 1107 2020
Novartis Investigative Site Recruiting
Tripoli, Lebanon, 1434
Oman
Novartis Investigative Site Recruiting
Muscat, Oman, 123
Spain
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Turkey
Novartis Investigative Site Recruiting
Adana, Turkey, 01250
Novartis Investigative Site Recruiting
Adana, Turkey, 01330
Novartis Investigative Site Recruiting
Antakya / Hatay, Turkey, 31100
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04657822    
Other Study ID Numbers: CSEG101A2401B
2020-004225-22 ( EudraCT Number )
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

URL: https://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
SCD
Vaso-occlusive Crisis
crizanlizumab
SEG101
Sickle cell disease
Sickle cell disorder
VOC
P-selectin
Sickle cell anemia
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn