EUCTR2011-002096-42-DE进行中（未招募）不适用
Biological Standardization of Ambrosia elatior Allergen ExtractDetermination of the Biological Activity in HEP units.An Open Monocenter Study. - Ambrosia Prick
ETI Pharma GmbH0 个研究点开始时间: 2012年5月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •> Subject has provided written informed consent including data protection declaration,
- •appropriately signed and dated by the subject
- •> Subject can be male or female of any race and ethnic group
- •> Women of child-bearing potential must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of ß-HCG) within 3 days prior to the Titrated Skin Prick Test, being the result available before any study procedure is performed. Woman of child-bearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (Defined as: age > 45 years plus 12 months of spontaneous amenorrhea or age > 45 years plus 6 months of spontaneous amenorrhea with serum FSH levels >40 mIE/mL).
- •> Age > 18 years and < 70 years at screening
- •> A documented positive case history of allergy related to ragweed (Ambrosia elatior)
- •> A positive SPT for Ambrosia elatior (ragweed) obtained within one year from the study procedure (tSPT).with a standardized product (ALYOSTAL Prick 100 IR Hohe Ambrosie, Stallergenes): mean wheal diameter = 3 mm.
- •> A mean wheal diameter = 7 mm as reaction to a SPT with histamine dihydrochloride 10 mg/ml (positive control).
- •> A positive test for specific IgE (RAST > 2) to Ambrosia elatior (ragweed) obtained within one year from the study procedure (tSPT).
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •> Subject is on treatment with ß-blockers.
- •> Subject is on treatment with tricyclic or tetracyclic antidepressants.
- •> Any disease requiring therapeutic use of systemic corticosteroids either as chronic treatment or in repeated, intermittent treatment.
- •> Diseases of the immune system, both autoimmune and immune deficiencies.
- •> Treatment with substances interfering with the immune system prior and during the study (for wash-out periods please refer to Section 9.1 and Appendix 1).
- •> Use of drugs that may interfere with the skin responses prior and during the study (please refer to Section 9.1 and Appendix 1).
- •> Severe uncontrolled diseases that could increase the risks concerning the subject’s safety, including but not limited to: cardiovascular insufficiency, any severe or unstable respiratory diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
- •> Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, severe peripheral vasculopathy, severe coronary insufficiency, cardiopathy, etc.)
- •> Dermographism, atopic dermatitis (local at the test site), urticaria.
- •> Pregnant or breastfeeding women
- •> Lack of cooperation which may interfere with the study
- •> Subjects with severe psychiatric, psychological or neurological disorders.
- •> Participation in any other clinical trial within 30 days prior to the subject inclusion in this clinical trial
- •> Specific immunotherapy with ragweed allergenic extract within the last 5 years.
- •> Previous participation in this study
- •> Alcohol, drug or medication abuse within the past year.
- •> Use of any other prohibited drug or non-drug therapy detailed in Section 9.
- •> Subjects who are employees at the investigational site or dependent and/or first degree relative or partner of the investigator.
- •> Subjects who are jurisdictionally or governmentally institutionalized
- •> Subject who plan to donate germ cells, blood, organs or bone marrow within 1 month after the end of the study.
研究者
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