NCT02163018已完成1 期
A First-in-human, Randomized, Double Blind, Placebo Controlled, Single-centre Study to Assess the Safety and Tolerability of HAL-MPE1 in Patients With Peanut Allergy
HAL Allergy1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy.
研究概览
简要总结
Currently, there is no effective causal treatment for peanut allergy. A chemically modified, aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. Results from in vitro and in vivo preclinical studies demonstrate the immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Male or female subjects aged 18-65 years.
- •A well-documented medical history of systemic reactions after ingestion of peanut
- •Positive food challenge at ≤1.5 gram peanut protein ingestion within the last 2 years
- •Positive serum specific anti-peanut and Ara h 2 Immunoglobulin E (IgE-test) (>0.7 kiloUnits(kU)/L) within the last 2 years
- •Forced expiratory volume at one second (FEV1)>70% of predicted value
排除标准
- •Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence) during challenge with peanuts.
- •Baseline serum tryptase level >20 µg/l
- •Known allergy or known hypersensitivity to (placebo) excipients
- •Participation in any interventional study aimed at desensitizing the peanut allergy in the past
- •Any specific immunotherapy (SCIT, SLIT or OIT) during the study period
- •Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- •Significant active malignancies or any malignant disease within the past 5 years
- •Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, or haematological disorders; or severe ongoing symptomatic allergic diseases
- •History of cardiovascular disease, uncontrolled hypertension or arrhythmias
- •Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
- •Use of systemic steroids within 4 weeks before start of the study and during the study
- •Treatment with β-blockers/ACE inhibitors
- •Vaccination within one week before start of therapy or during study
- •Anti-IgE/anti-Tumor necrosis factor (TNF) therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study
- •Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
- •Pregnancy (test performed at screening), lactation or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
- •Alcohol, drug or medication abuse within the past year
- •Any clinically significant abnormal laboratory parameter at screening
- •Lack or expected lack of cooperation or compliance
- •Severe psychiatric, psychological, or neurological disorders
- •Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators
研究组 & 干预措施
HAL-MPE1
Experimental
Subcutaneous administration of increasing doses of HAL-MPE1.
干预措施: HAL-MPE1 (Drug)
Placebo
Placebo Comparator
Subcutaneous administration of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy.
时间窗: up to 20 weeks
* Occurrence of early and late local reactions * Occurrence of early and late systemic reactions * Occurrence of adverse events (clinically relevant abnormalities of the physical examination will be documented as adverse events) * Changes in laboratory values, vital signs, ECG and lung function.
次要结局
- Change in serum levels of allergen specific immunoglobulins(before and after 15-20 weeks of treatment)
- Change in basophil histamine release test(before and after 15-20 weeks treatment)
- Change in titrated skin prick test(before and after 15-20 weeks of treatment)
研究者
研究点 (1)
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