Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- 18 ≤ age ≤ 80 years
- Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- ...
- 18 ≤ age ≤ 80 years
- Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
- Total liver volume ≥ 2500 mL
Exclusion Criteria
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Treatment with somatostatin analogues within six months before baseline
- Use of UDCA in 3 months before baseline
- ...
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Treatment with somatostatin analogues within six months before baseline
- Use of UDCA in 3 months before baseline
- Use of oral anticonceptives or estrogen supplementation
- Intervention (aspiration or surgical intervention) within six months before baseline
- Renal dysfunction (MDRD-Glomerular filtration rate< 30 ml/min/1.73m2)
- Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
- Mental illness that interferes with the patient ability to comply with the protocol
- Acute cholecystitis or frequent biliary colic attacks
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
- Acute stomach or duodenal ulcers
- Patients with a kidney transplant
- Inflammation of small intestine or colon
- 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
- Use of drugs that can interact with UDCA, such as colestyramine, aluminium hydroxide or cyclosporin
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
- 18 ≤ age ≤ 80 years
- Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- ...
- 18 ≤ age ≤ 80 years
- Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
- Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
- Total liver volume ≥ 2500 mL
Exclusion Criteria
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Treatment with somatostatin analogues within six months before baseline
- Use of UDCA in 3 months before baseline
- ...
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Treatment with somatostatin analogues within six months before baseline
- Use of UDCA in 3 months before baseline
- Use of oral anticonceptives or estrogen supplementation
- Intervention (aspiration or surgical intervention) within six months before baseline
- Renal dysfunction (MDRD-Glomerular filtration rate< 30 ml/min/1.73m2)
- Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
- Mental illness that interferes with the patient ability to comply with the protocol
- Acute cholecystitis or frequent biliary colic attacks
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
- Acute stomach or duodenal ulcers
- Patients with a kidney transplant
- Inflammation of small intestine or colon
- 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
- Use of drugs that can interact with UDCA, such as colestyramine, aluminium hydroxide or cyclosporin
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
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