ACTRN12626000839303进行中（未招募）4 期
Upadacitinib in addition to steroids for the initial treatment of acute severe ulcerative colitis (ASUC): Evaluating the efficacy, safety and feasibility of upadacitinib in addition to steroids for the initial treatment of ASUC
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •a). Aged between 18 to 65
- •b) Have ability to give written informed consent;
- •c) Have confirmed ASUC defined by the modified Truelove and Witts criteria;
- •d) Being admitted for management with intravenous corticosteroids;
- •e) Laboratory assessments at screening within the following parameters:
- •a. Haemoglobin greater than or equal to 80 g/L
- •b. Absolute neutrophil count greater than or equal to 1.5 x 10^3/µL
- •c. Absolute lymphocyte count greater than or equal to 0.5 x 10^3/µL
- •d. Platelets greater than or equal to 100 x 10^3/µL
- •e. Aspartate aminotransferase and alanine aminotransferase less than or equal to 2 x upper limit of normal (ULN)
- •f. Total bilirubin less than or equal to 2 x ULN
- •g. Alkaline phosphatase less than 3 x ULN
- •h. Estimated glomerular filtration rate greater than 60 mL/min
排除标准
- •a) Evidence of fulminant UC (toxic megacolon as evidenced by transverse colon diameter greater than or equal to 60mm and one of: fever [T greater than or equal to 37.80C], tachycardia [pulse rate greater than or equal to 90 beats per minute]);
- •b) Pregnant or breastfeeding;
- •c) Women of reproductive potential unless using effective contraception during treatment and for 4 weeks following the final dose of upadacitinib.
- •d) Evidence of infection on clinical evaluation;
- •e) History of solid organ or haematological malignancy, significant cardiorespiratory disease, severe hepatic impairment, thrombophilia or thromboembolic disorder;
- •f) Any absolute contraindication to steroids;
- •g) History of ischaemic colitis, radiation colitis, ileoanal pouch;
- •h) History of ileostomy or colostomy;
- •i) History of HIV, hepatitis B, hepatitis C, or active or latent tuberculosis;
- •j) History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or varicella zoster virus central nervous system infections;
- •k) History of faecal microbiota transplantation within 2 weeks of presentation;
- •l) Inability to take oral medications;
- •m) Concomitant treatment with strong CYP3A4 inhibitors or inducers;
- •n) Patients who have received live or attenuated vaccines within 28 days;
- •o) Be part of any other interventional trial;
- •p) Any unstable or chronic medical condition, including, but not limited to, cardiac, pulmonary, hepatic (e.g., cirrhosis), or psychiatric problem (including alcohol or drug abuse) that, in the opinion of the investigator, would make the participant unsuitable for the study or would prevent compliance with the study protocol
研究者
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