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

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.

ClinicalTrials.gov Identifier: NCT04662931

Novartis Reference Number: CSEG101A2403

Last Update: Apr 01, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Sickle Cell Disease (SCD)
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jul 14, 2021
Completion date 
Aug 20, 2024
Gender 
All
Age(s)
16 Years and older (Child, Adult, Older Adult)

Interventions

Drug
crizanlizumab
Crizanlizumab will be taken by IV infusion, at Week 1 Day 1, Week 3 Day 1 and all 4 weeks thereafter.

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Locations

India
Novartis Investigative Site
Recruiting
Hyderabad, 500018
Andhra Pradesh
India
Novartis Investigative Site
Recruiting
Raipur, 492099
Chhattisgarh
India
Novartis Investigative Site
Recruiting
Kozhikode, 673008
Kerala
India
Novartis Investigative Site
Recruiting
Bhubaneswar, 751003
Odisha
India
Novartis Investigative Site
Recruiting
Hyderabad, 500082
Telangana
India
Novartis Investigative Site
Recruiting
Lucknow, 226014
Uttar Pradesh
India
Novartis Investigative Site
Recruiting
Kolkata, 700014
West Bengal
India
Novartis Investigative Site
Recruiting
Guwahati, 781003
-
India

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]