EUCTR2020-000554-97-HU进行中（未招募）1 期
A Phase I, Open-Label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children = 5 to 11 Years of Age with Mild, Moderate, or Severe Asthma (TRAILHEAD) - TRAILHEAD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
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
- •1Written informed consent and written informed assent and any locally required authorisation obtained from the subject and legal representative prior to any study related procedure taking place.
- •2Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1).
- •Type of Subject and Disease Characteristics
- •3Documented physician diagnosed asthma for at least 6 months prior to Visit 1. If the subject 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.
- •4Documented treatment with total daily dose of either low, medium, or high dose ICS for at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020) with stable dose for at least 3 months prior to Visit 1.
- •6Inclusion criterion 6 (historical or current airway reversibility) removed with version 3.0 of Clinical Study Protocol.
- •7Pre bronchodilator (BD) FEV1 of = 50% of predicted normal value at Visit 1.
- •11Body weight = 16 kg at Visit 1 and Visit 2 (Day 1).
- •12Inclusion criterion 12 (Body mass index for age percentiles) removed with version 4.0 of Clinical Study Protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •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
- •Subjects are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1History of any clinically significant disease or disorder other than asthma which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
- •2History of a deterioration in asthma or asthma exacerbation that required a burst of systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day 1).
- •3Exclusion criterion 3 (previous exclusion for intra-articular glucocorticosteroids for conditions other than asthma) removed with version 3.0 of Clinical Study Protocol.
- •4History of hospitalisation (overnight admission) for asthma within 3 months of Visit 1, up to and including Visit 2 (Day 1).
- •5History of a life threatening asthma exacerbation requiring intubation or mechanical ventilation.
- •6History of systemic corticosteroid use for the maintenance treatment of asthma within 6 weeks of Visit 1, up to and including Visit 2 (Day 1) and discouraged until EOS.
- •11History of cancer.
- •Prior/Concurrent Clinical Study Experience
- •17History of hypersensitivity or anaphylactic reaction to any biologic therapy.
- •Diagnostic assessments
- •22Any clinical signs, symptoms, or abnormal findings during screening that may be indicative of past or present MIS-C.
- •Other Exclusions
- •31Participants who have had a confirmed COVID-19 infection and have not fully recovered (based on Investigator judgement) for at least 8 weeks prior to Visit 1.
- •32Participants with a history of severe COVID-19 infection requiring hospitalisation.
- •33Receipt of any COVID-19 vaccine 28 days prior to Visit 2 (Day 1).
研究者
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