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:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT01315795
Eligibility Criteria:
Inclusion Criteria:
* Liver volume ≥ 4 liter
* ≥ 20 liver cysts
* Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
* Abdominal distention perceived as uncomfortable
* Frequent abdominal pain
* Early satiety
* Nausea (with the inclusion of dyspeptic complaints)
* Dyspnea
* Diagnosed with ADPKD or ADPLD
* Male and female patients of 18 years and older
* Written informed consent
Exclusion Criteria:
* Creatinine clearance \< 20 ml/min
* Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
* Hormonal replacement therapy
* Hormonal contraception
* Pregnant or lactating
* Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
* Planned to undergo any surgery of the liver during study participation
* Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
* Patients with known allergies to somatostatin or its analogues or any of its components
* Patients who received somatostatin analogues in the 6 months preceding study inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01315795
Study Brief:
Protocol Section:
NCT01315795