An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Vaso-occlusive Crises.

About the study

Sickle cell disease (SCD) is a genetic blood disorder. Crizanlizumab has been approved in India and other countries 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 is 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.

Study point of contact

Novartis Pharmaceuticals
Novartis Pharmaceuticals
+41613241111
[email protected]

Locations

8 India sites

Age

> 16 Years

Phase

Phase 4

Study type

Interventional

Age

16 Years -

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

Signed informed consent
Male or female participant aged 16 years and older
Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography (HPLC). All SCD genotypes are eligible.
History of VOC leading to healthcare visit prior to screening visit
Participants must meet the following central laboratory values at the screening visit:

Absolute Neutrophil Count ≥1.0 x 109/L Platelet count ≥75 x 109/L Hemoglobin: for adults (Hb) ≥4.0 g/dL and for adolescents (Hb) ≥5.5 g/dL Glomerular filtration rate ≥ 45 mL/min/1.73 m2 using CKD-EPI formula Direct (conjugated) bilirubin < 2.0 x ULN Alanine Aminotransferase (ALT) < 3.0 x ULN ECOG performance status ≤2 for adults and Karnofsky Performance Scale ≥ 50% for adolescents.

participation restrictions

Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug. History of severe hypersensitivity reaction to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
Participant has received crizanlizumab and/or other P-selectin inhibitor prior to the study or plans to receive it during the duration of the study.
Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the Investigator, could cause unacceptable safety risks or compromise participation in the study.
Any condition which, in the opinion of the investigator, is likely to interfere with the successful collection of the measurements required for the study.
Participant has documented immunogenicity to a prior biological drug.
Participants who are on active treatment with Voxelotor, other investigational drug or other monoclonal antibody, or intend to initiate the same during the course of the trial.
Pregnant females or females who have given birth within the past 90 days prior screening or who are breastfeeding.
Women of childbearing potential unless using highly effective methods of contraception during dosing and for 15 weeks after stopping treatment
Significant bleeding disorder
Active HIV infection
Active Hepatitis B infection
Positive test for Hepatitis C RNA
Malignant disease
Active infection or immune deficiency

Locations

  • Hyderabad, Andhra Pradesh, India, Novartis Investigative Site, 500018 [Recruiting]
  • Raipur, Chhattisgarh, India, Novartis Investigative Site, 492099 [Recruiting]
  • Kozhikode, Kerala, India, Novartis Investigative Site, 673008 [Recruiting]
  • Bhubaneswar, Odisha, India, Novartis Investigative Site, 751003 [Recruiting]
  • Hyderabad, Telangana, India, Novartis Investigative Site, 500082 [Recruiting]
  • Lucknow, Uttar Pradesh, India, Novartis Investigative Site, 226014 [Recruiting]
  • Kolkata, West Bengal, India, Novartis Investigative Site, 700014 [Recruiting]
  • Guwahati, India, Novartis Investigative Site, 781003 [Recruiting]
Last updated 2022-03-31