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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05020873
Other study ID # CSEG101AIC05
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 4, 2021
Est. completion date August 31, 2023

Study information

Verified date January 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multicenter, prospective, single-arm observational non-interventional study (NIS), which will be conducted in various countries in the Middle East and India.


Description:

The study is designed to collect information on the utilization and effectiveness of crizanlizumab treatment in SCD patients under routine clinical practice conditions, to which the physician has made an independent decision to prescribe crizanlizumab.


Recruitment information / eligibility

Status Terminated
Enrollment 44
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 99 Years
Eligibility Inclusion Criteria: 1. Male and female patients with clinical diagnosis of SCD (based on laboratory parameters) of any genotype. 2. Patients newly initiated on treatment with locally approved crizanlizumab. 3. Patients aged 16 years or older at crizanlizumab initiation. Exclusion Criteria: 1. Patients who did not provide informed consent. 2. Patients who received a stem cell transplant at time of enrollment. 3. Patients who participated in or are participating in a clinical trial at time of enrollment or in the 12 months prior to starting commercial crizanlizumab. 4. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Crizanlizumab
Prospective observational study. There is no treatment allocation. Patients administered crizanlizumab, that have started before inclusion of the patient into the study will be enrolled.

Locations

Country Name City State
Bahrain Novartis Investigative Site Manama
Kuwait Novartis Investigative Site Al Ahmadi
Qatar Novartis Investigative Site Doha
Saudi Arabia Novartis Investigative Site Dammam
Saudi Arabia Novartis Investigative Site Jazan
United Arab Emirates Novartis Investigative Site Al Ain Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Bahrain,  Kuwait,  Qatar,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized rate of healthcare visit and home-managed (VOCs) requiring a medical facility visit The annualized rate of VOCs is defined as the total number of pain crises for a patient occurring from the date of initial infusion with crizanlizumab (commercially available) to the last contact date of the study end date × 365 divided by the number of days during that same time period.
This calculation accounts for early dropouts or lost to follow-up by extrapolating the VOC rate of every patient to 1 year.
12 months
Secondary Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home. Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Dose of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home. Dose of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Duration of use of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home. Duration of use of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Number of healthcare visit and home-managed (VOCs) leading to hospitalization Number of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Type of healthcare visit and home-managed (VOCs) leading to hospitalization Type of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Duration of healthcare visit and home-managed (VOCs) leading to hospitalization Duration of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected. Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S. Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S to be collected.
SCPD-S: Sickle Cell Pain Diary - Self Report
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S. Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S to be collected.
SCPD-S: Sickle Cell Pain Diary - Self Report
month 12 and month 24
Secondary Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Percentage of patients with acute and chronic complications/ end organ damage related to SCD Percentage of patients with acute and chronic complications/ end organ damage related to SCD to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Frequency of patients on blood transfusions Frequency of patients on blood transfusions to be collected. Blood transfusions: simple/ exchange/ chronic/ episodic Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Frequency of patients with SCD-related Healthcare Resource Utilization (HRU) Frequency of patients with SCD-related Healthcare Resource Utilization (HRU) to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary Number of patients with clinical laboratory parameters abnormalities Number of patients with clinical laboratory parameters abnormalities to be collected Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
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