EUCTR2018-000326-58-FR进行中（未招募）1 期
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real-World, Open-Label, Quality of Life Study - Quality of Life study of AR101 CODIT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
入选标准
- •1. Aged 4 to 17 years, inclusive, at screening
- •2. Written informed consent from subjects, as appropriate per local requirements, and legal
- •guardian/parent (or both parents where required by local authorities) of subjects who are
- •3. Written assent from subjects who are minors, as appropriate per local requirements
- •4. Written informed consent from the parent/caregiver who will complete relevant questionnaires during the study
- •5. History of physician-diagnosed immunoglobulin (Ig) E-mediated peanut allergy that includes the onset of characteristic signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food. In general, characteristic signs and symptoms of IgE-mediated allergic reactions are objective and affect the target organs of skin, gastrointestinal (GI) tract, upper/lower respiratory tract, cardiovascular system, or a combination of target organs
- •6. Mean wheal diameter on SPT to peanut = 8 mm greater than the negative saline control at screening
- •7. Serum IgE to peanut of = 14 kUA/L at screening
- •8. For sexually active females of childbearing potential, use of a highly effective method of birth control, defined as one that results in a low failure rate (ie, < 1% per year) when used consistently and correctly
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Uncertain clinical diagnosis of peanut allergy
- •2. History of severe or life-threatening anaphylaxis or anaphylactic shock within 60 days before screening
- •3. History of eosinophilic esophagitis (EoE); other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”); or recurrent GI symptoms of any etiology
- •4. History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- •5. Severe persistent asthma
- •6. Mild or moderate asthma (criteria steps 1-4; NHLBI, 2007) that is uncontrolled or difficult to control
- •7. History of high-dose corticosteroid medication use (eg, > 3 days at 1-2 mg/kg of prednisone or equivalent)
- •8. History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen, including malignancies within 5 years before screening and autoimmune diseases
- •9. History of cardiovascular disease including uncontrolled or inadequately controlled hypertension
- •10. Use of beta-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants
- •11. Unable to discontinue antihistamines 5 half-lives of the medication before the SPT, first day of dose escalation, and food challenges
- •12. Lack of an available palatable vehicle food to which the subject is not allergic
- •13. Allergy to oat
- •14. Use of any therapeutic antibody or any immunomodulatory therapy (including immunosuppressive medications) except aeroallergen or venom immunotherapy used in the maintenance phase within 6 months before screening
研究者
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