A Prospective, Multi-centre, Observational Study to Profile Chronic Cholestatic Liver Diseases in Patient Population Receiving Udiliv in India - The Splendid Study

Abbott India Limited0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•A patient can be included in the study if he/she meets all of the following inclusion criteria:
•1. Adult male or non-pregnant female patient aged 18 to 65 years.
•2. Presence of chronic CLD as diagnosed by the physician.
•3. A patient in whom the decision to prescribe Udiliv (according to the local label) has been taken by the treating physician during the normal course of therapy.
•4. Patient who has given written authorization to provide data for the study.

•Patients presenting with any of the following criteria will not be eligible for the study:
•1. Contraindications to Udiliv treatment (including hypersensitivity) according to the local label.
•2. Hepatocellular or metastatic liver carcinoma.
•3. Severe liver disease including but not limited to ascites, hepatic encephalopathy, hypoalbuminemia, coagulopathy.
•4. Child Pugh C Classification as diagnosed by the physician
•5. Pregnancy or lactation.
•6. Concomitant use of hepatotoxic drugs
•7. Previous enrollment in the present study.
•8. Other conditions that make the patientâ??s participation impossible (by investigator judgment).

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