Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers. - ELATE

Phase 1

• Conditions: Isolated polycystic liver disease; MedDRA version: 12.1Level: LLTClassification code 10048834Term: Polycystic liver disease; MedDRA version: 12.1Level: PTClassification code 10048834Term: Polycystic liver disease

• Registration Number: EUCTR2009-016640-39-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-24
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.