EUCTR2017-001861-25-SE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
- 106
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
- •5. Positive for GAD65A but < 50 000 IU/ml
- •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. combined (estrogen and progestogen containing)
- •c. oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
- •d. intrauterine device
- •e. intrauterine hormone-releasing system (for example, progestin-releasing coil)
- •f. bilateral tubal occlusion
- •g. vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- •h. male partner using condom
- •i. abstinence from heterosexual intercourse
- •For males of childbearing potential:
- •a. condom (male)
- •b. abstinence from heterosexual intercourse
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •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. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
- •5. A history of anemia or significantly abnormal hematology results at screening
- •6. A history of epilepsy, head trauma or cerebrovascular 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 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 Diamyd/placebo treatment)
- •15. 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
- •16. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
研究者
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