CTRI/2021/08/035635招募中3 期
A Phase III, Prospective Multicentric, Clinical Study in the Management of Pregnancy Induced Cholestasis to Evaluate the Efficacy and Safety of Ursodeoxycholic Acid (Udiliv) Tablets [PICTURE Study]. - PICTURE STUDY
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age > 19 years
- •2.Gestational age of >= 28 weeks at the time of study enrolment but less than or equal to 33 weeks
- •3.Body weight between 40 kg and 90 kg (both inclusive)
- •4.Confirmed diagnosis of OC (ICP), which is characterised by consistent pruritus associated with elevated levels of serum transaminases (ALT > 40 U/L or AST > 37 U/L) and raised serum bile acids (>= 10 µmol/L)
- •5.Able to understand and comply with the requirements of the study, and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed
- •6.Voluntary informed consent for taking the study drug until their delivery and also willing to be followed until their delivery
- •7.Agrees to provide the information on perinatal and maternal outcomes at or after delivery
- •8.Anticipated to require at least 4 weeks of UDCA therapy after inclusion
排除标准
- •1.History or current diagnosis of hepatic viral infections (Hepatitis A, B, C, and E virus related liver diseases, Epstein Barr virus, cytomegalovirus, Herpes simplex virus), human immunodeficiency virus infection, chronic liver diseases like primary biliary cirrhosis, primary sclerosing cholangitis, dermatologic diseases, metabolic diseases like diabetes (including alcohol abuse), other causes of cholestasis, eclampsia, acute fatty liver of pregnancy, autoimmune liver disease, obstructive hepatobiliary disease, calcified stones, gall bladder disease, inflammatory bowel disease, skin diseases, allergic reactions, haematological disorders or other disorders that may cause pruritus or elevated levels of bile and serum aminotransferases
- •2.Any other conditions or diseases that Investigator considers as inappropriate for a patient to participate in the study
- •3.History of any relevant allergy or hypersensitivity to the study drug or its excipients
- •4.Obstetric ultrasonography suggestive of fetal growth restriction/ abnormalities
- •5.High risk pregnancies. For, eg, multiple pregnancies, advanced maternal age, etc.
- •6.Willing to continue taking the prohibited medication(s), including bile acid sequestering agents like cholestyramine and colestipol, antacids containing aluminium hydroxide or aluminium oxide, and drugs affecting lipid metabolism like oestrogens, oral contraceptives, and lipid-lowering drugs like bezafibrate, clofibrate, ciprofibrate during the conduct of the study
- •7.Not able or not willing to attend the visits or follow the procedures according to the protocol
- •8.Subjects who are determined as being the risk group for COVID-19 as per applicable national guidelines.
研究者
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