NCT01361347已完成4 期
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
详细描述
Eligibility criteria:
Age 6 - 16 yrs
- IgE-mediated milk allergy
- and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms
Outcome measures:
- number of patients with successful desensitization (195 - 200 ml milk per day)
- number of patients with adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE-mediated milk allergy
- •An immediately positive challenge test result to milk prior to inclusion
排除标准
- •Not willing to participate
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 12 months
次要结局
- Number of participants drinking 2 dl/day of milk (success in desensitization)(12 months)
研究者
Marita Paassilta
MD, PhD, Paediatric Allergist
Tampere University Hospital
研究点 (2)
Loading locations...
相似试验
已完成
4 期
A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of AgePoliomyelitisNCT02580201Fidec Corporation154
终止
1 期
A Safety Study of SGN-2FF for Patients With Advanced Solid TumorsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellBreast NeoplasmsUrinary Bladder NeoplasmCarcinoma, Squamous Cell of Head and NeckGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaColorectal NeoplasmsNCT02952989Seagen Inc.47
已完成
4 期
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)Vaccines, CombinedHexavalent VaccineNCT05289271Merck Sharp & Dohme LLC168
已完成
不适用
Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary AngioedemaHereditary Angioedema (HAE)NCT01059526Shire81
已完成
3 期
Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and AboveCovid19NCT05021016Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"150
