Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug384 | BNT162b1 Wiki | 0.41 |
drug16 | 0.9% saline Wiki | 0.41 |
drug2490 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
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D014652 | Vascular Diseases NIH | 0.71 |
D000755 | Anemia, Sickle Cell NIH | 0.35 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 2 clinical trials
The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.
Description: Confirm appropriate dosing of crizanlizumab in participants aged 2 to < 18 years (Parts A)
Measure: PK (AUCd15) after 1st dose Time: Day 15Description: Confirm appropriate dosing of crizanlizumab in participants aged 2 to < 18 years (Parts A)
Measure: PD (AUCd15) after 1st dose Time: Day 15Description: Confirm appropriate dosing of Crizanlizumab in participants aged 2 to < 18 years old
Measure: PK (AUCtau) after multiple dose Time: Week 15Description: Confirm appropriate dosing of Crizanlizumab in participants aged 2 to < 18 years old
Measure: PD (AUCtau) after multiple dose Time: Week 15Description: Confirm appropriate dosing of crizanlizumab in participants aged 2 to < 18 years (Parts A)
Measure: PK (Cmax) after 1st dose and multiple dose Time: Week 1 and Week 15Description: Confirm appropriate dosing of crizanlizumab in participants aged 6 months to less than 24 months of age (Part B)
Measure: PK pre-dose concentrations Time: Week 1 to Week 19Description: Safety of crizanlizumab in participants aged 6 months to < 18 years (Parts A and B)
Measure: Frequency of any adverse events (AEs) as a measure of safety and tolerability Time: 6 months, 2 yearsDescription: To assess the long-term efficacy of crizanlizumab in 6 months to < 18 year old participants at the time of study entry (Parts A and B)
Measure: Annualized rate Vaso Occusive Crisis (VOC) events leading to healthcare visit in clinic/ER/hospital Time: 6 months, 2 yearsDescription: To assess the long-term efficacy of crizanlizumab in 6 months to < 18 year old participants at the time of study entry (Parts A and B)
Measure: Annualized rate Vaso Occusive Crisis (VOC) events treated at home (based on documentation by health care provider following phone contact with the patient) Time: 6 months, 2 yearsDescription: To assess the long-term efficacy of crizanlizumab in 6 months to < 18 year old participants at the time of study entry (Parts A and B)
Measure: Annualized rate each subcategory of VOC event (uncomplicated pain crisis, acute chest syndrome, hepatic sequestration, splenic sequestration, priapism) Time: 6 months, 2 yearsDescription: To assess the long-term efficacy of crizanlizumab in 6 months to < 18 year old participants at the time of study entry (Parts A and B)
Measure: Annualized rate hospitalizations and ER visits (both overall and VOC-related) Time: 6 months, 2 yearsDescription: To assess the long-term efficacy of crizanlizumab in 6 months to < 18 year old participants at the time of study entry (Parts A and B)
Measure: Annualized rate days of ER/hospitalization (both overall and VOC-related) Time: 6 months, 2 yearsDescription: To assess the long-term efficacy of crizanlizumab in 6 months to < 18 year old participants at the time of study entry (Parts A and B)
Measure: Annualized rate of dactylitis events Time: 6 months, 2 yearsDescription: To assess other safety measures in participants aged 6 months to < 18 years at the time of study entry
Measure: Number, seriousness, severity, and causality assessments of treatement emergent adverse events and other data as considered appropiate. Time: 6 months, 2 yearsDescription: To assess other safety measures in participants aged 6 months to < 18 years at the time of study entry
Measure: Absolute change from baseline in hemoglobin Time: Baseline, 6 months, 2 yearsDescription: To assess other safety measures in participants aged 6 months to < 18 years at the time of study entry
Measure: Immunogenicity: measurement of anti-drug antibodies (ADA) to crizanlizumab Time: Week 1, Week 3, Week 15, Week 27 and End of Treatment (EOT)Description: To assess other safety measures in participants aged 6 months to < 18 years at the time of study entry
Measure: Electrocardiogram (ECGs) at relevant PK time points Time: Screening, Week 7, Week 11, week 15, week 27 and Week 51Description: To assess other safety measures in participants aged 6 months to < 18 years at the time of study entry
Measure: Growth and sexual maturation assessments (Tanner stage) Time: Screening, Week 51 and End of Treatment (EOT)Description: Characterize long-term PK and PD of crizanlizumab in participants aged 6 months to >18 years
Measure: PK pre-dose concentrations prior to each study drug dose. Time: Week 1, Week 3, Week 7, Week 15, Week 19, Week 23, Week 27, Week 31, Week 35, Week 39, Week 43, Week 47 and Week 51Description: Characterize long-term PK and PD of crizanlizumab in participants aged 6 months to >18 years
Measure: Percentage P-selectin inhibition prior to dosing Time: Week 3, Week 15, Week 27 and Week 51The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.
Description: Level of soluble P-selectin in ng/ml.
Measure: Soluble P-selectin level Time: Day 3 after randomization or day of hospital discharge, whichever is earlierDescription: Level of soluble P-selectin in ng/ml.
Measure: Soluble P-selectin level Time: Day 7 after randomizationDescription: Level of soluble P-selectin in ng/ml.
Measure: Soluble P-selectin level Time: Day 14 after randomizationDescription: Level of D-dimer in mg/L.
Measure: D-dimer level Time: Day 3 after randomizationDescription: Level of D-dimer in mg/L.
Measure: D-dimer level Time: Day 7 after randomizationDescription: Level of D-dimer in mg/L.
Measure: D-dimer level Time: Day 14 after randomizationDescription: Level of VWF antigen (percentage).
Measure: VWF level Time: Day 3 after randomizationDescription: Level of VWF antigen (percentage).
Measure: VWF level Time: Day 7 after randomizationDescription: Level of VWF antigen in (percentage).
Measure: VWF level Time: Day 14 after randomizationDescription: Level of C-reactive protein (CRP) in mg/dL.
Measure: CRP level Time: Day 3 after randomizationDescription: Level of C-reactive protein (CRP) in mg/dL.
Measure: CRP level Time: Day 7 after randomizationDescription: Level of C-reactive protein (CRP) in mg/dL.
Measure: CRP level Time: Day 14 after randomizationDescription: Change in the clinical status over 14 days as measured by an ordinal scale that is the first assessment of the clinical status on a given study day. The scale is as follows: 0 = Uninfected; no viral RNA detected = Ambulatory; asymptomatic; viral RNA detected = Ambulatory; symptomatic; independent = Ambulatory; symptomatic; assistance needed = Hospitalized; no oxygen therapy = Hospitalized; oxygen by mask or nasal prongs = Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow = Hospitalized; intubation and mechanical ventilation, partial pressure of oxygen / fraction of inspired oxygen (pO2/FIO2) ≥ 150 or oxygen saturation / FIO2 (SpO2/FIO2) ≥ 200 = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 or vasopressors = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) = Dead
Measure: Change in clinical status as assessed by the World Health Organization (WHO) Ordinal Scale for COVID-19 Trials Time: Daily up to day 14 after randomizationDescription: Time (days) to hospital discharge
Measure: Time to hospital discharge Time: Up to 30 days after randomizationDescription: Safety of crizanlizumab will by assessed by adverse events, serious adverse events, and suspected unexpected serious adverse reactions.
Measure: Safety of Crizanlizumab as assessed by adverse events Time: Up to day 14 after randomizationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports