Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- 18 ≤ age ≤ 80 years
- ...
- Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- 18 ≤ age ≤ 80 years
- Total liver volume ≥ 2500 mL
- Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
Exclusion Criteria
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
- Use of UDCA in 3 months before baseline
- 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
- ...
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
- Use of UDCA in 3 months before baseline
- 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
- Acute stomach or duodenal ulcers
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Use of oral anticonceptives or estrogen supplementation
- Patients with a kidney transplant
- Acute cholecystitis or frequent biliary colic attacks
- Intervention (aspiration or surgical intervention) within six months before baseline
- Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
- Renal dysfunction (MDRD-Glomerular filtration rate< 30 ml/min/1.73m2)
- Inflammation of small intestine or colon
- Use of drugs that can interact with UDCA, such as colestyramine, aluminium hydroxide or cyclosporin
- Treatment with somatostatin analogues within six months before baseline
Summary
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Polycystic Liver Disease
- Polycystic Liver Disease (PLD)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
We investigated whether ursodeoxycholic acid was able to reduce total liver volume in polycystic liver disease.
We investigated whether ursodeoxycholic acid was able to reduce total liver volume in polycystic liver disease.
Inclusion Criteria
- Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- 18 ≤ age ≤ 80 years
- ...
- Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- 18 ≤ age ≤ 80 years
- Total liver volume ≥ 2500 mL
- Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
Exclusion Criteria
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
- Use of UDCA in 3 months before baseline
- 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
- ...
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
- Use of UDCA in 3 months before baseline
- 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
- Acute stomach or duodenal ulcers
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Use of oral anticonceptives or estrogen supplementation
- Patients with a kidney transplant
- Acute cholecystitis or frequent biliary colic attacks
- Intervention (aspiration or surgical intervention) within six months before baseline
- Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
- Renal dysfunction (MDRD-Glomerular filtration rate< 30 ml/min/1.73m2)
- Inflammation of small intestine or colon
- Use of drugs that can interact with UDCA, such as colestyramine, aluminium hydroxide or cyclosporin
- Treatment with somatostatin analogues within six months before baseline
Tracking Information
- NCT #
- NCT02021110
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Biodonostia Health Research Institute
- Investigators
- Principal Investigator: Joost PH Drenth, dr. Radboud University Medical Centre Nijmegen, the Netherlands
- Joost PH Drenth, dr. Radboud University Medical Centre Nijmegen, the Netherlands