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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1813 | Lanadelumab Wiki | 0.82 |
| drug432 | Bacille Calmette-Guérin (BCG) Wiki | 0.50 |
| drug2521 | Placebo Comparator Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000799 | Angioedema NIH | 1.00 |
| D054179 | Angioedemas, Hereditary NIH | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 2 clinical trials
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 392The purpose of this study is to evaluate the safety and efficacy of repeated subcutaneous (SC) administrations of lanadelumab in preventing angioedema attacks in adolescents and adults with non-histaminergic angioedema with normal C1-INH and in adults with acquired angioedema (AAE) due to C1-INH deficiency.
Description: An angioedema 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). Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 will be assessed.
Measure: Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 Time: Day 0 through Day 182Description: Number of participants achieving attack-free status during the treatment period of day 0 through day 182 will be assessed.
Measure: Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 Time: Day 0 through Day 182Description: Moderate attack is defined as grade 2 (some assistance may be needed, no or minimal medical intervention/therapy required), Severe attack is defined as grade 3 (some assistance usually required, medical intervention/therapy required, hospitalizations possible). Number of investigator-confirmed moderate or severe angioedema attacks during the treatment period of day 0 through day 182 will be assessed.
Measure: Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 Time: Day 0 Through Day 182Description: Number of investigator-confirmed angioedema attacks during the presumed steady state period of day 70 through day 182 will be assessed.
Measure: Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 Time: Day 70 through Day 182Description: Number of participants achieving attack-free status during the presumed steady state period of day 70 through day 182 will be assessed.
Measure: Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 Time: Day 70 through Day 182Description: Number of investigator-confirmed moderate or severe angioedema attacks during the presumed steady state period of day 70 through day 182 will be assessed.
Measure: Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 Time: Day 70 through Day 182Description: Number of participants with maximum attack severity during the presumed steady state period of day 70 through day 182 will be assessed.
Measure: Number of Participants with Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 Time: Day 70 through Day 182Description: Number of participants with maximum attack severity during treatment period of day 0 through day 182 will be assessed.
Measure: Number of Participants with Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 Time: Day 0 through Day 182Description: The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 0 through Day 182 will be calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 0 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 0 through Day 182.
Measure: Time to First Angioedema Attack After Day 0 Through Day 182 Time: Day 0 Through Day 182Description: The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 70 through Day 182 will be calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 70 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 70 through Day 182.
Measure: Time to First Angioedema Attack After Day 70 Through Day 182 Time: Day 70 through Day 182Description: Efficacy evaluation period will consist of two periods: Day 0 (after study drug administration) through Day 182 (the end of treatment period), presumed steady-state period from Day 70 through Day 182. Run in period will be 4 weeks and may be extended up to 8 weeks to determine their baseline attack rate. The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period will be expressed as a monthly (28 days) angioedema attack rate. Number of participants achieving at least 50 percent (%), 70%, 90% and 100% reduction in the investigator-confirmed normalized number of attacks per 4 weeks during each of the efficacy evaluation periods relative to the observation period NNA will be assessed.
Measure: Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) per 4 Weeks during each of the Efficacy Evaluation Periods Relative to the Observation Period NNA Time: Day 0 Through Day 182Description: The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period will be expressed as a monthly (28 days) angioedema attack rate. Number of participants achieving normalized number of attacks < 1.0 per 4 weeks during each of the efficacy evaluation periods will be assessed.
Measure: Number of Participants Achieving Normalized Number of Attacks (NNA) Less than (<)1.0 per 4 weeks During Each of the Efficacy Evaluation Periods Time: Day 0 Through Day 182, Day 70 through Day 182Description: A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP 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: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. AESI will include hypersensitivity reactions, events of disordered coagulation such as bleeding AESI, hypercoagulable AESI. Number of participants with TEAEs including AESI and SAE will be assessed.
Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) Time: From start of the study up to follow up (Day 196)Description: Plasma Concentrations of lanadelumab will be assessed.
Measure: Plasma Concentrations of Lanadelumab Time: Day 0, 4, 28, 56, 84, 112, 140, 168 and 182Description: Plasma Kallikrein 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, 4, 28, 56, 84, 112, 140, 168 and 182Description: Number of participants with neutralizing or non-neutralizing antidrug antibodies in plasma will be assessed.
Measure: Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Time: Day 0, 28, 56, 84, 112, 140, 168 and 182Description: The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema. The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AEQoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items has a five point response scale ranging from 1 (Never) to 5 (Very Often).
Measure: Change in Total Angioedema Quality of life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 Time: Day 0 through Day 182Alphabetical 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