NCT05020873

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
4 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

August 19, 2021

Last Update Submit

June 21, 2024

Conditions

Sickle Cell Disease

Keywords

NISsickle cell diseaseSCDcrizanlizumab

Outcome Measures

Primary Outcomes (1)

  • 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 Ă— 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 Outcomes (14)

  • Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.

    Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

  • Dose of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.

    Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

  • Duration of use of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.

    Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

  • Number of healthcare visit and home-managed (VOCs) leading to hospitalization

    Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

  • Type of healthcare visit and home-managed (VOCs) leading to hospitalization

    Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

  • +9 more secondary outcomes

Study Arms (1)

Crizanlizumab

Patients initiated on treatment with commercially available crizanlizumab

Other: Crizanlizumab

Interventions

CrizanlizumabOTHER

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.

Crizanlizumab

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with SCD initiated on treatment with commercially available crizanlizumab at sites

You may qualify if:

  • Male and female patients with clinical diagnosis of SCD (based on laboratory parameters) of any genotype.
  • Patients newly initiated on treatment with locally approved crizanlizumab.
  • Patients aged 16 years or older at crizanlizumab initiation.

You may not qualify if:

  • Patients who did not provide informed consent.
  • Patients who received a stem cell transplant at time of enrollment.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Manama, 20525, Bahrain

Location

Novartis Investigative Site

Al Ahmadi, 52700, Kuwait

Location

Novartis Investigative Site

Doha, 305, Qatar

Location

Novartis Investigative Site

Dammam, 32263, Saudi Arabia

Location

Novartis Investigative Site

Jizan, 82943, Saudi Arabia

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

crizanlizumab

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

November 4, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)KU(1)QA(1)SA(2)