Recruitment

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.
Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
...
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.
Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
Total liver volume ≥ 2500 mL
18 ≤ age ≤ 80 years

Exclusion Criteria

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

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

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.
Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
...
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.
Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms:
Total liver volume ≥ 2500 mL
18 ≤ age ≤ 80 years

Exclusion Criteria

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

Locations

Amsterdam
Nijmegen, Gelderland
San Sebastian
Amsterdam
Nijmegen, Gelderland
San Sebastian

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