EUCTR2021-003764-27-NL进行中（未招募）1 期
A randomized, placebo-controlled, double-blind, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease - POSITANO (POlycystic liver Safety and effIcacy TriAl with subcutaNeous Octreotide
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Camurus AB
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Male or female patient, =18 years at screening
- •Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) with 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
- •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 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Surgical intervention for PLD within 3 months before screening. For
- •sclerotherapy patients, at least 6 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
- •Symptomatic 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
- •Use of oral contraceptives or estrogen supplementation within 3 months before screening
- •Poorly controlled diabetes (hemoglobin A1c =10%) at screening
- •Patients with a known history of hypothyroidism, unless they have been on adequate and stable replacement thyroid hormone therapy for at least 3 months before the first dose of the IMP.
- •Uncontrolled hypertension defined by a systolic blood pressure of >160 mmHg and/or diastolic blood pressure of >100 mmHg at screening
- •History of significant cardiac disease or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following:
- •a. History of myocardial infarction, angina pectoris or coronary artery bypass graft within 6 months before screening
- •b. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block or high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II and third-degree atrioventricular block)
- •c. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- •i. Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia
- •ii. Treatment with concomitant medication(s) with a Known risk of Torsades de Pointes that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives or 7 days (whichever is longer) before the first dose of IMP
- •iii. Patients with a baseline QTc interval corrected by Fridericia's formula >450 msec for males and >470 msec for females at screening
- •Patients with vascular compromise, including, but not limited to, mesenteric thrombosis, portal hypertension and thrombocytopenia (platelet counts less than 100x109/L)
- •Pregnant, lactating or planning to be pregnant during the trial
- •History of solid organ transplantation. Exception for kidney transplant patients
- •Contraindications to, or interference with, MRI assessments, as dictated by local hospital regulations
研究者
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