EUCTR2009-016640-39-NL
Active, not recruiting
Phase 1
Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers. - ELATE
Radboud University Nijmegen Medical Centre0 sites44 target enrollmentDecember 24, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Isolated polycystic liver disease
- Sponsor
- Radboud University Nijmegen Medical Centre
- Enrollment
- 44
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers.polycystic liver disease10019654NL-OMON32654niversitair Medisch Centrum Sint Radboud44
Active, not recruiting
Phase 1
Introduction of everolimus is associated with a reduction in the dosage of calcineurine-inhibitors in patients with a pulmonary graft who suffer from a notable chronic renal insuffisance.Patient who received a pulmonary transplant and who show notable renale insuffisance (DFG < 50ml/min/1.73m²) which has been progressive over the last two years or chronical renal insuffisance which progresses fast (a los of >50% DGF in 3 months) and isotopical glomerural filtration < 45 ml/min.EUCTR2006-001945-32-BEB Erasme15
Active, not recruiting
Phase 1
Everolimus (RAD001) in combination with intravenous carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer - RAD001 and carboplatin in pretreated metastatic breast cancerEUCTR2008-006055-52-DECharité - University Hospital of Berlin58
Recruiting
Phase 4
Investigating the occurrence of everolimus long-term side effects by follow up of everolimus trough blood concentrations.NL-OMON50487Medisch Universitair Ziekenhuis Maastricht40
Completed
Phase 2
Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NETGastrointestinal NeoplasmsNCT01567488Grupo Espanol de Tumores Neuroendocrinos43