NL-OMON43811已完成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 allergy specific immunotherapy) FAST
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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.
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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