EUCTR2022-002356-39-SE进行中（未招募）1 期
DiaPrecise, A Phase II Open Label Study to evaluate the safety andfeasibility of intralymphatic administration of Diamyd® inindividuals at risk for Type 1 diabetes carrying the HLA DR3-DQ2haplotype - DiaPrecise
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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. Written informed consent/assent from the individual and the individual’s parents or caretaker(s)
- •according to local regulations.
- •2. Males and females aged =8 and <18 years old at the time of Screening.
- •3. Possess the HLA DR3-DQ2 haplotype.
- •4. Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A,
- •ZnT8A or IAA).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 16
- •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. Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association
- •[ADA] classification).
- •2. Fasting glucose > 7 mmol/L (126 mg/dl), 2-hour-OGTT plasma glucose > 11.1 mmol/L (200
- •mg/dL) or HbA1c > 6.5% (48 mmol/mol) at the screening Visit.
- •3. Treatment with any anti-diabetic medication, including the use of external insulin.
- •4. Participation in any other clinical trial testing pharmaceutical treatments.
- •5. Recent (past 12 months) or current treatment with immunosuppressant therapy, including
- •chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable.
- •Short courses (e.g., =5 days) of oral or intra-articular injections of steroids will be permitted on
- •6. History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately
- •treated, or any other contraindication to use of Vitamin D.
- •7. History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of
- •continuous motor unit activity in proximal muscles
- •8. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g.,
- •Alhydrogel) or lidocaine (local anesthetic)
- •9. Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
- •10. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus
- •Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first dose of study drug; or
- •planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
- •11. Ongoing diagnosed post-COVID19 syndrome.
- •12. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
- •Individuals with previous hepatitis C infection that is now cured may be eligible.
- •13. Any clinically significant concomitant medical condition, including but not limited to other
- •autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a
- •history of renal transplantation or neurological that in the opinion of the investigator would
- •interfere with trial participation or procedures. Celiac disease with adequate diet as well as
- •stable autoimmune thyroiditis will be permitted.
- •14. Any clinically significant abnormal findings detected during Screening that might jeopardize the
- •individual’s safety or ability to complete the trial.
- •15. Females who are lactating or pregnant (for females who have started menstruating the
- •possibility of pregnancy must be excluded by urine ßHCG onsite prior to the study drug
- •administration).
- •16. Males or females not willing to use adequate contraception, if sexually active, until 90 days
- •after the last Diamyd administration. Adequate contraception is as follows:
- •For females of childbearing potential (FOCBP)
- •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. refraining from heterosexual intercourse if that is the preferred and usual lifestyle of the
- •For sexually active males
- •b. Abstinence from heterosexual intercourse if that is the preferred and usual lifestyle of the
- •c. Vasectomy
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