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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04662931
Recruitment Status : Active, not recruiting
First Posted : December 10, 2020
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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 or disease Intervention/treatment Phase
Sickle Cell Disease (SCD) Drug: crizanlizumab Phase 4

Detailed Description:

Sickle cell disease (SCD) is a genetic blood disorder, caused by a mutation in the β-globin gene, which early on progresses into a systemic disease. Vaso-occlusion is a hallmark of SCD and can lead to serious acute and chronic complications.

Crizanlizumab has been approved in US, 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.

The study is open label and single armed. 140 patients will be treated with crizanlizumab for about one year at a dose of 5 mg/kg in addition to receiving standard of care.

The primary objective is to assess frequency, severity and causality of serious adverse events (SAEs) during the treatment period. Secondary objective is to assess overall safety and tolerability of crizanlizumab.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : August 20, 2024
Estimated Study Completion Date : August 20, 2024


Arm Intervention/treatment
Experimental: Crizanlizumab
Participants will receive Crizanlizumab at a dose of 5.0 mg/kg.
Drug: crizanlizumab
Crizanlizumab will be taken by IV infusion, at Week 1 Day 1, Week 3 Day 1 and all 4 weeks thereafter.
Other Name: SEG101




Primary Outcome Measures :
  1. Percentage of patients with at least one serious adverse event (SAE) with 2-sided 95% confidence interval (CI) [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Incidence of serious adverse events (SAEs)

  2. Percentage of patients with SAEs of grades >=3 [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Severity of serious adverse events (SAEs)

  3. Percentage of patients with treatment-related SAEs of all grades [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Causality of serious adverse events (SAEs)

  4. Percentage of patients with treatment-related SAEs of grades >=3 [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Causality of severe serious adverse events (SAEs)


Secondary Outcome Measures :
  1. Percentage of patients with at least one treatment-emergent adverse event (AE)(new or worsening from baseline) [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Incidence of treatment-emergent adverse events (AEs)

  2. Percentage of patients with AEs of grades >=3 [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Severity of adverse events (AEs)

  3. Percentage of patients with treatment-related AEs of all grades [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Causality of adverse events (AEs)

  4. Percentage of patients with treatment-related AEs of grades >=3 [ Time Frame: During treatment period - from Week 1 Day 1 (first dose) to safety follow up visit (105 days after Week 51 Day 1, or 105 days after last dose in case of early discontinuation) ]
    Causality of severe adverse events (AEs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662931


Locations
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India
Novartis Investigative Site
Raipur, Chhattisgarh, India, 492099
Novartis Investigative Site
Kozhikode, Kerala, India, 673008
Novartis Investigative Site
Bhubaneswar, Odisha, India, 751003
Novartis Investigative Site
Hyderabad, Telangana, India, 500082
Novartis Investigative Site
Lucknow, Uttar Pradesh, India, 226014
Novartis Investigative Site
Kolkata, West Bengal, India, 700014
Novartis Investigative Site
Guwahati, India, 781003
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04662931    
Other Study ID Numbers: CSEG101A2403
2020-003625-31 ( EudraCT Number )
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com

URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sickle cell disease
Sickle cell disorder
SCD
Sickle cell anemia
Hemoglobin SC disease
Sickling disorder due to hemoglobin S
Vaso-occlusive crisis
VOC
P-selectin
Crizanlizumab
SEG101
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn