EUCTR2019-004638-40-Outside-EU/EEA进行中（未招募）1 期
An Open-label Study to Evaluate the Pharmacokinetics and Pharmacodynamics and Long-term Safety of Benralizumab Administered Subcutaneously in Children with Severe Eosinophilic Asthma. - TATE
AstraZenenca AB0 个研究点目标入组 30 人开始时间: 2020年2月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Parent(s)/guardian are able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. If applicable, the participant must be able and willing to give assent to take part in the study according to the local requirement.
- •2.Patient must be 6 to 11 years of age inclusive (6 to 14 years of age inclusive in Japan), at the time of signing the ICF.
- •3.Diagnosis of severe asthma, defined by the regional guidelines (ie, National Institutes of Health [NIH], Global Initiative for Asthma [GINA], American Thoracic Society [ATS], European Respiratory Society [ERS], Japanese Society of Pediatric Allergy and Clinical Immunology [JSPACI], etc.), for at least 12 months prior to Visit 1. If the patient is naïve to the study site, the participant/guardian must self-report a physician diagnosis of asthma and the investigator must confirm by review of medical history with the participant/guardian.
- •4.A previously confirmed history of two or more exacerbations requiring treatment with systemic corticosteroids* and/or hospitalization in the 12 months prior to Visit 1, despite the use of ICS, or a persistent need for oral corticosteroid maintenance treatment to maintain asthma control, for at least 3 of the last 12 months prior to Visit 1, despite the use of ICS. *For patients receiving maintenance oral corticosteroids, the OCS treatment for the exacerbations must have been a two-fold increase or greater in the dose.
- •5.Eosinophilic airway inflammation that is related to asthma characterized as eosinophilic in nature as indicated by peripheral blood eosinophil count of =150 cells / µL at Visit 1.
- •6.A well-documented requirement for regular treatment with ICS: total daily dose equivalent to =250 µg fluticasone propionate, or =400 µg budesonide (=320 µg budesonide ex-actuator), or =200 µg fluticasone furoate, or =220 µg mometasone furoate, or =160 µg ciclesonide, or =1000 µg triamcinolone acetonide, or =500 µg beclomethasone dipropionate, or =200 µg beclomethasone dipropionate (HFA) in the 12 months prior to Visit 1, with or without maintenance oral corticosteroids. Medium dose ICS as per local guidelines will also satisfy the inclusion criterion after agreement with the Study Physician.
- •7.Current treatment with at least 1 additional controller medication, such as inhaled LABA, leukotriene receptor antagonist, long acting anti-muscarinic agent, or theophylline, since at least 3 months prior to Visit 1.
- •8.Forced expiratory volume in 1 second (FEV1): Flow/ volume curve indicating airflow obstruction at either Visit 1 or 2 (performed prior to first dose of study medication), associated with: a pre-bronchodilator FEV1 = 110% predicted normal, or, FEV1/Forced Vital Capacity ratio = 0.8.
- •9.Body weight =15 kg.
- •10.Male or female
- •11.Females of childbearing potential (FOCBP) who are sexually active, as judged by the investigator, must commit to consistent and correct use of an acceptable method of contraception for the duration of the study and for 4 months after the last dose of IP.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any history of life-threatening asthma (eg, requiring intubation)
- •2.Clinically important pulmonary disease other than asthma such as active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia
- •3.Previous diagnosis of pulmonary or systematic disease, other than asthma, that is associated with elevated peripheral eosinophil counts such as allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and hypereosinophilic syndrome
- •4.Ever been diagnosed with malignant disease
- •5.Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, immunological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:Affect the safety of the patient throughout the study, Influence the findings of the study or their interpretations, Impede the patient’s ability to complete the entire duration of the study
- •6.History of anaphylaxis to any biologic therapy
- •7.Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete the entire duration of the study
- •8.Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening period, which in the opinion of the investigator may put the patient at risk or interfere with study assessments
- •9.Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
- •10.A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent and assent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
- •11.Alanine aminotransferase or aspartate aminotransferase level =1.5 times the upper limit of normal confirmed during the screening period
- •12.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
- •13.Use of immunosuppressive medication, including, but not limited to, methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy, within 3 months prior to Visit 1. Chronic maintenance corticosteroid for the treatment of asthma is allowe.
- •14.Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
- •15.Receipt of any marketed (eg, omalizumab, mepolizumab, or off-label benralizumab) or investigational biologic within 4 months or 5 half-lives, whichever is longer, prior to Visit .
- •16.Receipt of live attenuated vaccines 30 days prior to the date of first dose of IP
- •17.Initiation of new allergen immunotherapy is not allowed within 30 days prior to Visit 1.However, allergen immunotherapy initiated prior to this period can be continued provided there is a gap of 7 days between the immunotherapy and IP administration.
- •18.Current use of any oral or ophthalmic non-selective ß-adrenergic antagonist (eg, propranolol)
- •19.Planned surgical procedures during the conduct of
研究者
相似试验
招募中
2 期
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in Pediatric Patients (6 to 17 Years of Age) with Heterozygous Familial Hypercholesterolemia10027424Heterozygous Familial HypercholesterolemiaFamilial HypercholesterolemiaNL-OMON53717Esperion Therapeutics, Inc.15
进行中（未招募）
不适用
A study evaluating the Pharmacokinetics and Tolerability of Lu AA21004 in Child and Adolescent Patients With Depressive or Anxiety DisorderEUCTR2010-020170-42-DEH. Lundbeck A/S48
进行中（未招募）
1 期
A study to evaluate how much bempedoic acid is in the body, and the effects and safety of bempedoic acid in children (6 to 17 years of age) with heterozygous familial hypercholesterolemia (a type of high cholesterol) receiving once daily oral dosing.MedDRA version: 21.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: LLTClassification code 10054380Term: Familial hypercholesterolemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10057079Term: Heterozygous familial hypercholesterolemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersHETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIAEUCTR2018-004084-31-DEEsperion Therapeutics, Inc.54
招募中
1 期
A study to evaluate how much bempedoic acid is in the body, and the effects and safety of bempedoic acid in children (6 to 17 years of age) with heterozygous familial hypercholesterolemia (a type of high cholesterol) receiving once daily oral dosing.HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIAEUCTR2018-004084-31-NLEsperion Therapeutics, Inc.54
进行中（未招募）
1 期
A study to evaluate how much bempedoic acid is in the body, and the effects and safety of bempedoic acid in children (6 to 17 years of age) with heterozygous familial hypercholesterolemia (a type of high cholesterol) receiving once daily oral dosing.HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIAEUCTR2018-004084-31-ESEsperion Therapeutics, Inc.54