EUCTR2014-003755-64-SE进行中（未招募）1 期
A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® in combination with Vitamin D on the progression to type 1 diabetes in children with multiple islet cell autoantibodies - DiAPREV-IT 2
Helena Elding Larsson0 个研究点目标入组 80 人开始时间: 2014年9月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •1.Children from four (4) to 17,99 years of age.
- •2.Positive GAD65Ab and at least one additional type 1 diabetes-associated autoantibody (IA-2Ab, ZnT8R/W/Q/AAb or IAA).
- •3.Written informed consent from the child and the child’s parents or legal acceptable representative(s) according to local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted).
- •2.Diabetes.
- •3.Treatment with any oral or injected anti-diabetic medications.
- •4.Significantly abnormal hematology results at screening.
- •5.Clinically significant history of acute reaction to vaccines or other drugs.
- •6.Treatment with any vaccine, other than influenza, within one month prior to the first dose of the study drug or planned treatment with vaccine up to two months after the last injection with the study drug.
- •7.A history of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
- •8.Participation in other clinical trials with a new chemical entity within the previous 3 months.
- •9.History of hypercalcemia.
- •10.Unwilling to abstain from other medication with Vitamin D during the study period.
- •11.Significant illness other than diabetes within 2 weeks prior to first dosing.
- •12.Known human deficiency virus (HIV) or hepatitis.
- •13.Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigators makes the patient non-eligible for the study.
- •14.Diabetes-protective HLA-DQ6-genotype.
- •15.Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine ßHCG onsite within 24 hours prior to the study drug administration)
- •16.Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last Diamyd administration. Adequate contraception is as follows:
- •For females of childbearing potential:
- •a.oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives (females)
- •b.intrauterine device (females)
- •c.intrauterine system (for example, progestin-releasing coil) (females)
- •d.vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
- •For males of childbearing potential:
- •a.condom (male)
研究者
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