Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01157858
Eligibility Criteria:
Inclusion Criteria:
* 18 \< age ≤ 70 years
* Polycystic liver disease (PCLD), defined as ≥ 20 liver cysts
* Total liver volume must be at least 2500 mL
* Symptomatic defined as ECOG-PS ≥ 1 (see fig 3.1)38, and having at least three out of ten PCLD symptoms:
* Abdominal pain
* Abdominal distension
* Abdominal fullness
* Dyspnea
* Early satiety
* Back pain
* Nausea/vomiting
* Anorexia
* Weight loss
* Jaundice
* Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
Exclusion Criteria:
* ADPKD patients
* Use of oral anticonceptives or estrogen supplementation
* Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the administration of study medication.
* Intervention (aspiration or surgical intervention) within three months before baseline
* Treatment with somatostatin analogues within three months before baseline
* Patients with a kidney transplant
* History or other evidence of chronic pulmonary disease associated with functional limitation
* History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
* 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 (fasting cholesterol \> 8 mmol/l) or hypertriglyceridaemia (\> 5 mmol/l) not controlled by lipid lowering therapy
* Granulocytopenia (white blood cell \< 3,000/mm3) or thrombocytopenia (platelets \< 100,000/mm3)
* 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 or one of its excipients
* Enrolment in another clinical trial of an investigational agent while participating in this study
* Moderate or severe reaction on contrast in medical history
* Treatment with I131 during the course of the trial
* Use of metformin
* Morbus Kahler or Morbus Waldenstrom with excretion of light chains in urine in medical history
* Kidney dysfunction (MDRD-GFR \< 60 ml/min/1.73m2 and ECC \< 60 ml/min, calculated by the Cockcroft-Gault formula); in case of decreased body muscle mass, exact ECC is measured using serum and urine creatinine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01157858
Study Brief:
Protocol Section:
NCT01157858