EUCTR2019-004523-21-IT进行中（未招募）1 期
A Phase 2 Study To Evaluate The Sensitivity, Specificity And Safety Of DBV1605, A Ready To Use Atopy Patch Test For The Diagnosis Of Non-Immunoglobulin E Mediated Cow’s Milk Allergy In Children - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
- •- Male or female subjects aged 1 month to 5 years at Screening Visit,
- •Subjects with a history of symptoms that are consistent with non-IgE mediated CMA as per Investigator's assessment, by either:
- •o Two or more gastrointestinal symptoms (vomiting, diarrhea, persistent distress/colic, regurgitation, constipation), that lasted at least 1 week within 1
- •month prior to Screening Visit
- •o Blood in stool,
- •Subjects with any type of diet containing regular cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) within 1 month prior to Screening Visit,
- •Subjects with a negative cow's milk SPT: mean wheal diameter <3 mm and negative control <1 mm.
- •Subjects may be included in the disease group if they do not meet, among other criteria, any of the following exclusion criteria:
- •Subjects with an established diagnosis of non-IgE mediated by a physician after appropriate diagnostic testing including cow's milk
- •protein challenge,
- •Breast-fed subject at Screening Visit,
- •Subjects with a history of confirmed food protein-induced enterocolitis syndrome,
- •Subjects with a convincing history of IgE-mediated CMA.
- •CONTROL GROUP
- •Subjects may be included in the control group only if they meet, among other criteria, the following inclusion criteria:
- •Male or female subjects aged 1 month to 5 years at Visit 1,
- •Subjects having no medical history of any type of allergy, including no history of IgE-mediated allergic reactions to cow's milk and with no medical history of any food allergy in their family (parents, sibling),
- •Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 1 month prior to Visit 1.
- •Subjects with negative cow's milk SPT: mean wheal diameter <3 mm and negative control <1 mm.
- •Subjects may be included in the control group if they do not meet, among other criteria, any of the following exclusion criteria:
- •Subjects with history of persistent gastro-intestinal symptoms including vomiting, diarrhea, distress/colic, regurgitation, constipation, blood in stool, for at least 4 consecutive weeks within the previous year.
- •Breast-fed subjects at Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •DISEASE GROUP
- •1 Subjects with an established diagnosis of non-IgE mediated CMA made by a physician after appropriate diagnostic testing including cow's milk protein challenge.
- •2 Breast-fed subjects at Screening Visit.
- •3 Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula within 1 month of
- •Screening Visit.
- •4 Subjects with a history of confirmed FPIES.
- •5 Any contraindication to a cow's milk challenge, in particular subjects with a history of severe anaphylactic reaction to cow's milk. Severe anaphylaxis is defined as Grade 3 of the Anaphylaxis Staging System, including:
- •Severe hypoxia, persistent hypotension or more than 20% drop in blood pressure, neurological compromise, or
- •Cyanosis or SpO2 = 92% at any stage, confusion, cardiovascular collapse, loss of consciousness, bradycardia, cardiac arrest.
- •6 Subjects with a convincing history of IgE-mediated CMA.
- •10 Known hypersensitivity to any of the DBV1605 components (except to milk proteins).
- •11 Known hypersensitivity to any component of the food challenge formula (except to milk proteins).
- •12 A history of any immunotherapy for CMA.
- •15 Any disorder in which epinephrine is contraindicated such as congenital cardiac malformation, uncontrolled hypertension, or serious ventricular arrhythmias.
- •17 Intake of leukotriene receptor antagonists or 5-lipooxygenase inhibitors within 30 days prior to Screening Visit.
- •18 Treatment with antihistamines within 1 to 7 days (depending on halflife and specified in APPENDIX 3) prior to Screening Visit or inability to discontinue antihistamines for the minimum wash-out periods required prior to SPT or food challenges.
- •19 Treatment with topical steroid applied on the back within 30 days prior to Screening Visit.
研究者
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