EUCTR2017-001861-25-ES进行中（未招募）1 期
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 109
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. T1D according to the ADA classification diagnosed =6 months at the time of screening
- •3. Age: =12 and <25 years old
- •4. Fasting C-peptide =0.12 nmol/L on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
- •5. Positive for GAD65A but < 50 000 random units
- •6. Females must agree to avoid pregnancy and have a negative urine pregnancy test.
- •Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. 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 post vasectomy 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: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •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 anti-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. A history of anemia or significantly abnormal hematology results at screening
- •5. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •6. Clinically significant history of acute reaction to vaccines or other drugs in the past
- •7. 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.
- •8. Participation in other clinical trials with a new chemical entity within the previous 3 months
- •9. Inability or unwillingness to comply with the provisions of this protocol
- •10. A history of alcohol or drug abuse
- •11. A significant illness other than diabetes within 2 weeks prior to first dosing
- •12. Known HIV or hepatitis
- •13. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the Diamyd/placebo treatment)
- •14. Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
- •15. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
研究者
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