An international, multicenter, randomized controlled clinical trial assessing the efficacy of Ursodeoxycholic acid as a volume reducing treatment for symptomatic polycystic livers - CURSOR

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•18 <= age <= 80 years
•Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as >= 20 liver cysts
•Total liver volume >= 2500 mL ;• Symptomatic defined as ECOG-PS >= 1 (2), and having at least three out of ten PCLD symptoms:
•- Abdominal pain
•- Abdominal distension
•- Abdominal fullness
•- Early satiety
•- Back pain
•- Nausea/vomiting
•- Anorexia
•- Weight loss
•- Jaundice
•Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.

•Use of oral anticonceptives or estrogen supplementation
•Use of UDCA in 3 months before baseline
•Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
•Intervention (aspiration or surgical intervention) within six months before baseline
•Treatment with somatostatin analogues within months before baseline
•Renal dysfunction (MDRD-GFR < 30 ml/min/1.73m2)
•Patients with a kidney transplant
•Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
•Acute cholecystitis or frequent biliary colic attacks
•Acute stomach or duodenal ulcers
•Inflammation of small intestine or colon
•Use of drugs that can interact with UDCA, such as colestyramine or aluminium hydroxide
•Enrolment in another clinical trial of an investigational agent while participating in this study
•History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
•Mental illness that interferes with the patient ability to comply with the protocol

发起方

niversitair Medisch Centrum Sint Radboud