EUCTR2018-004011-44-GB进行中（未招募）1 期
A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus. - TURRIFIC Protocol Version 8
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
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
- Female
入选标准
- •Women will be considered eligible for inclusion into the trial with the following criteria:
- •Severe ICP (defined as pruritus with raised total serum BA =40 µmol/L) confirmed
- •Viable pregnancy between 14+0 and 33+6 weeks gestation inclusive
- •No known lethal fetal anomaly
- •Singleton pregnancy
- •Obstetric care in a consultant-led unit
- •Aged 18 years or over
- •Written informed consent has been obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •A decision has already been made for delivery within the next 48 hours
- •There is allergy to any component of the UDCA or RIF tablets
- •The woman is taking other medication that has a significant interaction with rifampicin treatment
- •There is a multi-fetal gestation
- •There is laboratory-confirmed active hepatitis A or hepatitis B, or positive serology for hepatitis C
- •There is current pre-eclampsia (ISSHP criteria)
- •There is a known primary hepatic disorder, including a-1-antitrypsin deficiency and autoimmune hepatitis, including primary biliary cholangitis
- •The woman is on current medication causing deranged liver enzymes
- •The woman is unwilling for her baby to have standard Vitamin K administration at birth
- •The woman has previously participated in TURRIFIC
研究者
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