NCT05478083招募中2 期
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Liver growth
研究概览
简要总结
Multicenter trial on the effect of the GnRH analogue leuprorelin on the growth of total liver volume in pre-menopausal women with very severe polycystic liver disease who, despite available therapy, experience growth and are heading for liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patient blinding is not possible, since leuprorelin will induce menopause related complaints.
Primary outcome is not reported to investigators until the study has finished. Outcome assessors are blinded for study subject and treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Diagnosis of polycystic liver disease defined as the presence of more than 10 liver cysts
- •Age between 18 to 45 (inclusive) years;
- •Very large liver for age, defined as the upper 10% of liver volumes in specific age categories (based on a retrospective polycystic liver disease registry, n=1.600 patients)
- •18-30 yr; height adjusted TLV > 2.0 L/m
- •30-35 yr; height adjusted TLV > 2.2 L/m
- •35-40 yr; height adjusted TLV > 2.5 L/m
- •40-45 years; height adjusted TLV > 3.0 L/m
- •Availability of at least 1 historical MRI or CT scan made between 5 to 1 years before baseline visit of this study
- •Ongoing liver growth, defined as an increase in absolute total liver volume between the historical MRI or CT scan and the MRI at screening of this trial
- •Since somatostatin analogues are proven efficacious therapy for polycystic liver disease at this time it is required that:
- •patients use a somatostatin analogue and still have confirmed liver growth; OR
- •patient have a specific reason not to use this medication, .e.g. patient used a somatostatin analogue in the past, but had to stop it due to inefficacy or because he/she did not tolerate it, patient has a contra-indication for using somatostatin analogues, no availability of somatostatin analogues
- •Voluntary written informed consent before performance of any study-related procedures not part of standard medical care, and able to read, comprehend, and respond to study questionnaires.
排除标准
- •Post-menopausal status or (vasomotor) symptoms indicating upcoming menopause
- •Anti Mullerian Hormone (AMH) measurement at screening visit <0.03 ng/ml.
- •Active desire to have children, pregnancy or breast-feeding
- •Contra-indications for leuprorelin, such as history of cardiovascular disease, history of osteoporosis or osteoporosis determined by DEXA-scan at screening (T score ≤ - 2.5), or a known intolerance for leuprorelin
- •Liver transplantation or liver surgery expected within 1.5 years, to the discretion of the study doctor
- •Use of hormonal oral contra-conception containing estrogen and/or progesterone. In contrast, a hormone containing uterine device is not an exclusion criteria.
- •Contra-indications for MRI assessments (such as implants) or not able or willing to undergo MRI scan for other reasons (e.g. claustrophobia, profound obesity)
- •Kidney transplantation or chronic use of immunosuppressive agents (such as cyclosporine, mycophenolic acid, tacrolimus but not prednisolone) for other indications
- •Severe hypertension, defined as a systolic blood pressure >160 mmHg and/or diastolic blood pressure > 100 mm Hg.
- •Clinically significant, uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which would affect the efficacy of safety analysis if the condition exacerbated during the study, or that may significantly interfere with study compliance, such as, but not restricted to, recurrent cholangitis, recurrent ascites or hepato-venous outflow obstruction, (history of) depression
- •Participation in other interventional studies at the same time.
研究组 & 干预措施
Direct start
Active Comparator
36 months of treatment with study medication
干预措施: Leuprorelin (Drug)
Delayed start
Other
First 18 months standard care, hereafter 18 months treatment with study medication
干预措施: Leuprorelin (Drug)
结局指标
主要结局
Liver growth
时间窗: 36 months
Liver volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months
次要结局
- Bloodpressure(36 months)
- Patient reported mental health(36 months)
- Patient reported physical health(36 months)
- Kidney growth(36 months)
- Sex hormone levels(36 months)
- Bone density(36 months)
- Weight(36 months)
- Length(1 month)
- Polycystic liver disease related complaints(36 months)
- Renal function(36 months)
- Heart rate(36 months)
- Abdominal circumference(36 months)
- Upper-arm-circumference(36 months)
- Menopause related complaints(36 months)
- The number of participants experciencing a (serious) adverse events(36 months)
- Symptoms of depression(36 months)
研究者
研究点 (2)
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