EUCTR2014-002522-12-DE进行中（未招募）1 期
European phase-II clinical trial evaluating efficacy of low dose rhIL-2 in patients with recently diagnosed type 1 diabetes - DIABIL-2
Assistance Publique - Hôpitaux de Paris (AP-HP)0 个研究点目标入组 138 人开始时间: 2015年3月4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
- 138
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
- •-Age 6-35 years old
- •-Male or female both using effective methods of contraception during treatment if sexually active.
- •-Specifically; Females (if sexually active) with childbearing potential must use contraceptive methods that are considered as highly-effective (pearl index < 1). The following methods are acceptable: Oral , injectable, or implanted hormonal contraceptives (with the exception of oral minipills ie low-dose gestagens which are not acceptable (lynestrenol and norestisteron), Intrauterine device, Intrauterine system (for example, progestin-releasing toit),
- •-beta HCG negative at inclusion;
- •-With type-1 diabetes:
- •Newly diagnosed (ADA criteria) at most three months between insulin initiation and anticipated start of experimental treatment
- •Positive for one or more of the autoantibodies typically associated with T1D
- •With a detectable peak C-peptide concentration during a standardised MMTT (=0.2pmol/ml)
- •patients with a stable blood glucose level and seric glycaemia between 60 mg/dL and 250 mg/dL verified at MMTT visit
- •- Absence of clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function;
- •- Normal cardiac function: no documented history of heart disease and absence of family history of sudden death, normal ECG especially QTc duration within normal value (<480ms)
- •- Free, informed and written consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 92
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Children under the age of 6 years old cannot be included
- •- Patient who, before inclusion, have been treated with other anti-diabetic medication than Insulin for more than 3 months consecutively
- •- Chronic adrenal insufficiency known or fasting ACTH =2.5 ULN normal at inclusion after control;
- •- Anti TPO present at inclusion and abnormal TSH and T4
- •- Anti-transglutaminase positive at inclusion
- •- Hypersensitivity to the active substance or to any of the excipients
- •- Any major health problem including: any severe or evolutive auto-immune/auto-inflammatory disease (other than type 1 diabetes) present at inclusion, any significant respiratory disease (such as moderate or severe COPD or asthma) only if requiring the chronic use of corticosteroids (whatever route of administration) and serious digestive malfunctions.
- •- Patient with existing malignancy or history of malignancy
- •- Major psychosocial instability with expected lack of compliance with insulin treatment, psychiatric pathology of patient or parents, or major problems of family dynamics;
- •- Signs of active infection;
- •- Any patient with obesity defined as BMI = 35
- •- Existence of a serious malfunction of a vital organ;
- •- History of organ allograft;
- •- Use of treatments not allowed in the Study
- •- Vaccination with alive attenuated virus within 4 weeks of the first injection of the induction period and during the whole maintenance period
- •- Pregnant female (confirmed by laboratory testing) or lactating
- •- Participation in another clinical trial in the previous 3 months;
- •- Lack of affiliation to a social security scheme (as a beneficiary or assignee).
研究者
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