drugset / Trial / NCT04662931

An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab in Sickle Cell Disease Patients

NCT04662931

Phase 4 Completed 140 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

Sickle cell disease (SCD) is a genetic blood disorder. Crizanlizumab is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in patients with SCD aged 16 years and older. The purpose of this local Phase IV study was to evaluate the safety of crizanlizumab specifically in Indian patients with SCD aged 16 years or older with a history of VOC leading to healthcare visit.

Timeline

Start
2021-07-14
Primary completion
2024-02-14
Completion
2024-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Crizanlizumab Monoclonal antibody 5 mg/kg Intravenous

Indications