ACTRN12620000239965进行中（未招募）2 期
A Phase 2, Randomised, Placebo Controlled Study Investigating the Efficacy of Baricitinib in New Onset Type 1 Diabetes Mellitus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 10 Years 至 30 Years（—）
- 性别
- All
入选标准
- •To be eligible for study entry, participants must satisfy all of the following criteria:
- •1.Male or female aged between 10 and 30 years (inclusive) at screening;
- •2.Diagnosis of T1D according to ADA criteria within 100 days prior to starting study drug;
- •3.Islet autoantibody positivity (one or more of: GADA, IA-2A, IAA (assessed within one week of commencing insulin therapy), ZnT8A);
- •4.Stimulated (peak or 90 min) C-peptide >0.2 nM during a 2-hour MMTT at the screening visit, or random C-peptide result >0.3 nM during the screening period;
- •5.Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study;
- •6.Be able to read, understand and give written informed consent;
- •7.Be willing to comply with intensive diabetes management.
排除标准
- •Participants will be excluded from the study if one or more of the following criteria are applicable:
- •1.Use of immunosuppressive or immunomodulatory therapies other than inhaled or topical glucocorticoids;
- •2.Current or past history of deep vein thrombosis or pulmonary embolism;
- •3.Impaired renal function defined by estimated glomerular filtration rate (according to the CKD-EPI) of < 60 mL/min/1.73 m2;
- •4.LDL cholesterol >4mmol/l;
- •5.Elevated liver function tests at screening:
- •a.Aspartate aminotransferase 2x ULN
- •b.Alanine aminotransferase 2 x ULN;
- •6.Clinically significant abnormal laboratory parameters at screening including but not limited to:
- •a.Hemoglobin < 8 g/L;
- •b.White blood cells <2500 cells/µl;
- •c.Lymphocyte count <750 cells/µl;
- •d.Platelets <50,000 cells/µl;
- •e.Neutrophils <1200cells/µL;
- •7.Known hypersensitivity to baricitinib;
- •8.Known malignancy with the exception of successfully treated non- metastatic basal cell and squamous cell carcinoma;
- •9.Pregnancy, a desire for pregnancy, breast feeding, or a desire to father a child during the study;
- •10.Patients with current or recent (within 12 weeks of screening) clinically significant comorbidity, including clinically serious viral, bacterial, fungal, or parasitic infection. Viral infections include HBV, HCV, EBV, HIV, recent herpes zoster and TB;
- •11.Treatment with any investigational product within 30 days or 5 half - lives (whichever is longer) prior to baseline visit, or concurrent participation in a clinical trial with an investigational product or device;
- •12.Experienced any of the following within 12 weeks of screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
- •13.Any serious medical condition within the previous 4 weeks which places the participant at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, haematological and neurological conditions or psychiatric illness/social situations that would limit compliance with study requirements;
- •14.Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the participant;
- •15.History of chronic alcohol abuse or IV drug abuse or other illicit drug abuse within 2 years prior to screening.
研究者
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