EUCTR2015-000276-10-PL进行中（未招募）1 期
FAST – Food Allergy Specific ImmunoTherapy A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish - FAST2015
Academisch Medisch Centrum bij de Universiteit van Amsterdam (AMC) Prof. dr. M. M. Levi, Dean & Chair0 个研究点目标入组 96 人开始时间: 2015年10月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
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
- •Subject having given a written informed consent before completing any study related procedure.
- •Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
- •For woman of child bearing potential:
- •-a negative urine pregnancy test at screening visit,
- •-the subject must receive/ use a medically effective contraceptive method during the study.
- •Convincing case history of allergy (immediate allergic reaction = 2 hours) to fish ingestion.
- •Specific IgE to fish by both a positive (3mm mean wheal diameter over negative control) SPT to cod extract and an ImmunoCAP = class 2 (0.70 kUA/L) for cod (f3) and rCyp c 1 at screening.
- •Positive DBPCFC with cod at screening visits.
- •Spirometry FEV1 = 80% of predicted values at screening.
- •Subject accepting to comply fully with the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Placebo-reaction in DBPCFC.
- •Reaction in the last (7th) dose of the DBPCFC.
- •Food anaphylaxis: anaphylactic shock (a score of 2 or 3 on cardiovascular/ neurologic symptoms according to PRACTALL (1): score 2 = drop in blood pressure and/or >20% from baseline, or significant change in mental status- score 3 = cardiovascular collapse, signs of impaired circulation/ unconscious) due to fish intake, both during the past and at screening DBPCFC.
- •Ongoing immunotherapy (IT) with any kind of allergen.
- •Ongoing or previous treatment with omalizumab.
- •Any clinical condition that contraindicates IT (EAACI guidelines) (8): serious immunological diseases, major cardiovascular disease, cancer, chronic infections, lack of compliance and severe psychological disorders.
- •Any significant clinical condition that the investigators judged might hamper the patient’s safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, mental disease, immunological and endocrine disease.
- •Chronic urticaria.
- •Severe atopic dermatitis or non-controlled atopic dermatitis.
- •Ongoing treatment with betablockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor II antagonists (ARA II).
- •Pregnancy or nursing.
- •Uncontrolled asthma (asthma, if present, should be well controlled according to GINA guidelines using any kind of drugs except oral corticosteroids and omalizumab).
- •An FEV1<80% of predicted value during screening spirometry.
- •Subject who has participated in a clinical trial within 3 months prior to this one.
- •Subject with a history of drug or alcohol abuse.
- •Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
- •Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines and/or leukotriene receptor antagonists five days prior each screening and treatment visit.
研究者
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2 期
FAST * Food Allergy Specific ImmunoTherapy<br>A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish<br>Food allergyhypersensitive1000170810016950NL-OMON43811Academisch Medisch Centrum10