EUCTR2004-003764-30-SE进行中（未招募）不适用
A Phase II, Randomised, Double-Blind, Placebo-controlled, Multi-centre Study to Investigate the Impact of Diamyd on the Progression of diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus
Diamyd Therapeutics AB0 个研究点目标入组 70 人开始时间: 2004年10月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. Male and female patients of any race between 10 and 18 years of age.
- •2. Type 1 diabetes mellitus diagnosed within the previous 18 months and the onset at least 14 days prior to Primary injection
- •3. C-peptide level above 0.1 nmol/l.
- •4. Presence of GAD65 antibodies
- •5. Written informed consent both from the patient and the guardian where applicable.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Secondary diabetes mellitus.
- •2.Treatment with immunosuppressant(s).
- •3. A history of anaemia or significantly abnormal haematology results at screening.
- •4. A history of epilepsy, head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles.
- •5. Clinically significant history of acute reaction to drugs in the past.
- •6. Treatment with any vaccine within one month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd.
- •7. Participation in other clinical trials with a new chemical entity within the previous 3 months.
- •8. Inability or unwillingness to comply with the provisions of this protocol.
- •9. A history of alcohol or drug abuse.
- •10. A significant illness other than diabetes within 2 weeks prior to first dosing.
- •11. HIV or hepatitis.
- •12. Females pregnant at the time of injection or plans for pregnancy during the next 13 months ( one year after 2 nd administration).
- •13. MODY- Maturity Onset Diabetes in the young, known or likely
- •14. Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study.
研究者
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