Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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drug323 | Antihemophilic Factor (Recombinant) Wiki | 1.00 |
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Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study in pediatric participants (<18 years of age) with severe hereditary von Willebrand disease (VWD) is: 1. To assess the efficacy, safety, and tolerability of recombinant von Willebrand Factor (rVWF), with or without ADVATE, in the treatment and control of nonsurgical bleeding events 2. To assess the efficacy and safety of rVWF with ADVATE during elective or emergency surgery 3. To determine the pharmacokinetic (PK) profile of rVWF
Description: Treatment success for rVWF-treated nonsurgical bleeding episodes (using a 4-point scale: Excellent, Good, Moderate, None).
Measure: Hemostatic Efficacy Time: Within 24 hours after the last infusion of study drug following the onset of the bleeding episode (if/when the severity and/or duration of the bleeding requires the infusion of the study drug)Description: If/when the severity and/or duration of the bleeding requires the infusion of the study drug.
Measure: Number of Treated Nonsurgical Bleeding Episodes with an Efficacy Rating of 'Excellent' or 'Good' Time: Throughout the study duration of approximately 6 yearsDescription: Assessed by by the operating surgeon, based on a 4-point ordinal scale: Excellent, Good, Moderate, None.
Measure: Elective or Emergency Surgery: Assessment of Hemostatic Efficacy - Immediately After Surgery Time: Immediately after surgeryDescription: Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None.
Measure: Elective or Emergency Surgery: Overall Assessment of Hemostatic Efficacy 24 hours After the Last Perioperative Infusion of rVWF Time: 24 hours after last perioperative rVWF infusionDescription: Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None.
Measure: Elective or emergency surgery: Overall Assessment of Hemostatic Efficacy Day 7 post-operative Time: Post-operative Day 7Description: Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None.
Measure: Elective or emergency surgery: Overall Assessment of Hemostatic Efficacy Day 14 post-operative Time: Post-operative Day 14Description: Tmax will be assessed.
Measure: Time to Reach Maximal Plasma Concentration (Tmax) Time: Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hoursDescription: Cmax will be assessed.
Measure: Maximal Plasma Concentration (Cmax) Time: Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hoursDescription: von Willebrand factor: antigen (VWF:Ag); von Willebrand factor: collagen binding capacity (VWF:CB).
Measure: Area Under the Plasma Concentration/Time Curve from 0 to 96 Hours Post-infusion (AUC0-96h) for VWF:Ag and VWF:CB Time: Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hoursAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
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