Isolated polycystic liver disease MedDRA version: 12.1 Level: LLT Classification code 10048834 Term: Polycystic liver disease MedDRA version: 12.1 Level: PT Classification code 10048834 Term: Polycystic liver disease
Conditions
Interventions
Product Name: Everolimus
Product Code: RAD001
Pharmaceutical Form: Tablet
Product Name: octreotide LAR
Product Code: unknown
Pharmaceutical Form: Powder and solvent for suspension for injection
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18-70 years of age - isolated polycystic liver disease, defined as at least 20 liver cysts - total liver volume must be at least 2500 mL - informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • ADPKD patients • Use of oral anticonceptives or estrogen suppletion • Females who are pregnant or breast-feeding • Intervention within three months before baseline • Patients with a kidney transplant • History of chronic pulmonary disease associated with functional limitation • History of severe cardiac disease • 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 • Symptomatic gallstones (octreotide decreases gall bladder volume) • Hypercholesterolemia or hypertriglyceridaemia not controlled by lipid lowering therapy • Granulocytopenia or thrombocytopenia • Infection with hepatitis B, hepatitis C, HIV, TBC (in medical history) • Mental illness that interferes with the patient ability to comply with the protocol • Drug or alcohol abuse within one year of baseline • Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin • Known hypersensitivity to everolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of polycystic liver volume;Secondary Objective: Reduction of symptoms;Primary end point(s): Reduction of liver volume from baseline to 48 weeks. | — |
Countries
Netherlands
Outcome results
None listed