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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT05281328
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient, ≥18 years at screening
* Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥1800 mL/m at screening
* Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen
* Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial
Exclusion Criteria:
* Surgical intervention for PLD within 3 months before screening
* Treatment with a somatostatin analogue (SSA) within 3 months before screening
* Non-responsive to previous treatment of PLD with an SSA as per the Investigator's assessment
* Systematic cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy
* Presence of extrahepatic cysts that, in the Investigator's opinion, may prevent the patient from safely participating in the trial
* Severe kidney disease, as defined by eGFR \<30 mL/min/1.73\^m2
* Severe liver disease defined as liver cirrhosis of Child-Pugh class C
* Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05281328
Study Brief:
Protocol Section:
NCT05281328