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Trial details
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Current status:
Approved
|
Date registered:
18/07/2023
Trial version(s)
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
History: 11/10/2021
Current: 11/10/2021
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Main Information
Primary registry identifying number
LBCTR2021104867
Protocol number
CSEG101A2401B
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Acronym
Scientific 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
Acronym
Brief summary of the study: English
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.
Brief summary of the study: Arabic
دراسة تمديد مفتوحة التسمية، متعددة المراكز، في المرحلة الرابعة لمرضى مصابين بداء الكريات المنجليّة أنجزوا دراسة سابقة حول كريزانليزوماب برعاية نوفارتيس
Health conditions/problem studied: Specify
Sickle Cell Disease
Interventions: Specify
Drug: Crizanlizumab Concentrate for solution for infusion for Intravenous use Other Name: SEG101
Key inclusion and exclusion criteria: Inclusion 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
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
6
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: 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
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Single Arm Study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
4
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Albania,Australia,Austria,Bahrain,Belgium,Brazil,Bulgaria, Lebanon,United Arab Emirates, United Kingdom, United States,South Africa,Norway, Oman, Qatar, Romania Denmark, Germany, Greece,Italy,France.
Name of IMP
Crizanlizumab
Year of authorization
2020
Month of authorization
12
Type of IMP
Others
Type of IMP: Specify
humanized monoclonal antibody
Pharmaceutical class
anti-P-selectin
Therapeutic indication
Sickle Cell Disease
Therapeutic benefit
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
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
10
Actual enrollment target size
5
Date of first enrollment: Type
Actual
Date of first enrollment: Date
29/12/2021
Date of study closure: Type
Actual
Date of study closure: Date
17/01/2029
Recruitment status
Recruiting
Date of completion
31/03/2023
IPD sharing statement plan
Yes
IPD sharing statement 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.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT04657822?term=CSEG101A2401B&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT04657822
Sources of Monetary or Material Support
Name
Novartis pharma services Inc.
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Adlette
Inati
Tripoli
Lebanon
961 (0) 3 228 033
adlette.inati@lau.edu.lb
Nini Hospital
Scientific
Hind
Khairallah
KFF Healthcare - Khalil Fattal et fils
Lebanon
+961 1512002 #271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils Sal
Public
Miguel
Abboud
Beirut
Lebanon
9613534213
ma56@aub.edu.lb
American University of Beirut Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Nini Hospital
Adlette Inati
Pediatric Hematology
Approved
American University of Beirut Medical Center
Miguel Abboud
Pediatric Hematology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Nini Hospital
08/10/2021
Nabil Kabbara
Nabil.kabbara@hopitalnini.com
+961 (0) 6 431 400 ext 1062
American University of Beirut Medical Center
14/12/2021
Fuad Ziyadeh
fz05@aub.edu.lb
961 (0) 1 350 000 ext:5445
Countries of Recruitment
Name
Lebanon
Belgium
Health Conditions or Problems Studied
Condition
Code
Keyword
sickle cell disease
Sickle-cell disorders (D57)
SCD
Interventions
Intervention
Description
Keyword
Consenting, IMP administration
Consenting, IMP administration
Consenting, IMP administration
Primary Outcomes
Name
Time points
Measure
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
Not Applicable - Study Completion
Not Applicable - Study Completion
Key Secondary Outcomes
Name
Time points
Measure
Number of participants with treatment emergent adverse events
from day of first dose of study medication to 105 days after last dose of study medication
from day of first dose of study medication to 105 days after last dose of study medication
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Investigator Letter-EMA CHMP Recommendation
30/05/2023
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