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There is one clinical trial.
The purpose of this phase 3, open-label, multicenter study is to evaluate the safety, PK, and PD of lanadelumab in children with age of 2 years to <12 years with Hereditary Angioedema (HAE).
Description: An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product or medicinal product. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, is an important medical event. Adverse events of special interest for this study are hypersensitivity reactions and disordered coagulation (hypercoagulability events and bleeding events).
Measure: Number of Participants with Adverse Events Including Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) Time: From start of study treatment up to Follow up (Day 392)Description: Plasma concentrations (cmax) of lanadelumab over the treatment period will be assessed.
Measure: Plasma Concentrations of Lanadelumab Over the Treatment Period Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Maximum observed concentration at steady state (Cmax,ss) of lanadelumab in plasma will be assessed.
Measure: Maximum Observed Concentration at Steady State (Cmax,ss) of Lanadelumab in Plasma Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Average concentration over Dosing interval at steady state (Cavg,ss) of lanadelumab in plasma will be assessed.
Measure: Average Concentration Over Dosing Interval at Steady State (Cavg,ss) of Lanadelumab in Plasma Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Predose concentration at steady state (Ctrough,ss) of lanadelumab in plasma will be assessed.
Measure: Predose Concentration at Steady State (Ctrough,ss) of Lanadelumab in Plasma Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Time to reach Cmax (tmax) of lanadelumab in plasma will be assessed.
Measure: Time to Reach Maximum Observed Concentration (Cmax) (tmax)of Lanadelumab in Plasma Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Area under the concentration-time curve over the dosing interval at steady state (AUCtau,ss) of lanadelumab in plasma will be assessed.
Measure: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Lanadelumab in Plasma Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Terminal half-life (t1/2) of lanadelumab in plasma will be assessed.
Measure: Terminal half-life (t1/2) of Lanadelumab in Plasma Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Apparent clearance (CL/F) of lanadelumab will be assessed.
Measure: Apparent clearance (CL/F) of Lanadelumab Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Apparent volume of distribution (V/F) of lanadelumab will be assessed.
Measure: Apparent Volume of Distribution (V/F) of Lanadelumab Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: The normalized number of investigator-confirmed HAE attacks during each efficacy evaluation period will be expressed as a monthly HAE attack rate. A HAE attack is defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Overall treatment period of the study is from Day 0 (after start of study drug administration) through Day 364 (Week 52).
Measure: Normalized Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Overall Treatment Period Time: From start of study treatment up to Follow up (Day 392)Description: Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]).
Measure: Normalized Number of Investigator-Confirmed HAE Attacks For Each Efficacy Evaluation Period Other Than the Overall Treatment Period Time: Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: Time to the first investigator-confirmed HAE attack (days) for each efficacy evaluation period will be calculated from the date and time of the first dose of lanadelumab for that efficacy evaluation period to the date and time of the first investigator-confirmed HAE attack after the first open-label dose for that efficacy evaluation period. Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]).
Measure: Time to the First Investigator-Confirmed Hereditary Angioedema (HAE) Attack for Each Evaluation Period Time: Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]).
Measure: Normalized Number of Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment for Each Efficacy Evaluation Period Time: Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]). Severe attack is defined as grade 3 (some assistance usually required, medical intervention/therapy required, hospitalizations possible), moderate attack is defined as grade 2 (some assistance may be needed, no or minimal medical intervention/therapy required).
Measure: Normalized Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks for Each Efficacy Evaluation Period Time: Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]). A high morbidity HAE attack is defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation <24 hours), hemodynamically significant (systolic blood pressure <90, requires intravenous (IV) hydration or associated with syncope or near-syncope) or laryngeal.
Measure: Normalized Number of High Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks for Each Efficacy Evaluation Period Time: Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: Characteristics of investigator-confirmed HAE attacks for each efficacy evaluation period includes duration, severity, attack location, and rescue medication use. Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]).
Measure: Number of Participants with Characteristics of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks for Each Efficacy Evaluation Period Time: Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: The number of particpiants who are attack-free will be summarized for each efficacy evaluation period. Efficacy evaluation period consists of overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52]), treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26]), treatment Period B (Day 183 through Day 364 [Week 52]), overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52]), presumed steady state period for treatment period A (Day 70 [Week 10] through Day 182 [Week 26]).
Measure: Number of Participants with Hereditary Angioedema (HAE) Attack-Free Status for Each Evaluation Period Time: Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364Description: pKal activity will be measured by biomarker cleaved high molecular weight kininogen (cHMWK )level to assess pharmacodynamics of lanadelumab.
Measure: Plasma Kallikrein (pKal) Activity Time: Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392Description: Immunogenicity will be measured based on the presence or absence of neutralizing or non-neutralizing Anti-drug Antibody (ADA) in plasma.
Measure: Number of Participants with Positive Immunogenicity Time: Day 0 (Pre-dose), Day 28, 84, 140, 182, 196, 252, 308, 364 and 392Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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.
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