EUCTR2014-001417-79-SE进行中（未招募）1 期
Open Label Pilot Trial in patients with recent-onset T1D to evaluate the safety, diabetes status and immune response of GAD-antigen (Diamyd®) therapy administered into lymph nodes in combination with an oral vitamin D regimen - DIAGNODE-1
inköping University0 个研究点目标入组 12 人开始时间: 2014年7月2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
- 12
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.Informed consent given by patients and/or patient’s parent (s) or legal acceptable representative(s) (guardian(s)) according to national regulations
- •2.Type 1 diabetes according to the ADA classification with < 6 months diabetes duration
- •3.Age 12.00-29.99 years at diagnosis of Type 1 diabetes
- •4.Fasting C-peptide =0.12 nmol/L
- •5.Pos GADA but < 50 000 random units
- •6.Females must agree to avoid pregnancy and have a negative urine pregnancy test
- •7.Patients of childbearing potential must agree to using adequate contraception, until 1 year after the last administration of GAD-Alum. Adequate contraception is as follows:
- •For females of childbearing potential:
- •a.oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- •b.intrauterine device
- •c.intrauterine system (for example, progestin-releasing coil)
- •d.vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
- •For males of childbearing potential:
- •e.condom (male)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- •2.Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- •3.Treatment with any oral or injected anti-diabetic medications other than insulin
- •4.Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
- •5.A history of anaemia or significantly abnormal haematology results at screening
- •6.A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •7.Clinically significant history of acute reaction to vaccines or other drugs in the past
- •8.Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.
- •9.Participation in other clinical trials with a new chemical entity within the previous 3 months
- •10.Inability or unwillingness to comply with the provisions of this protocol
- •11.A history of alcohol or drug abuse
- •12.A significant illness other than diabetes within 2 weeks prior to first dosing
- •13.Known human immunodeficiency virus (HIV) or hepatitis
- •14.Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the GAD-Alum treatment)
- •15.Males or females not willing to use adequate contraception until 1 year after the last GAD-Alum treatment
- •16.Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study
- •17.Deemed by the investigator not being able to follow instructions and/or follow the study protocol
研究者
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