2023-506637-30-00已完成3 期
The AGAINST-PLD; An investigator-driven, randomized, open label clinical trial assessing efficacy of leuprorelin to halt disease progression in PLD
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The primary outcome variable is liver growth rate (in % per year), calculated over the first 18 months of the trial (screening-18 months) based on liver volumes measured on MRI, comparing the direct start group and delayed start group.
研究概览
简要总结
To determine whether lowering estrogen and progesterone levels with the GnRH agonist leuprorelin decreases liver growth rates (in percent per year) in pre-menopausal women with severe polycystic liver disease during 18 months of treatment, comparing the direct start group (treated) and delayed start group (untreated).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •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) o 18-30 yr; height adjusted TLV > 2.0 L/m o 30-35 yr; height adjusted TLV > 2.2 L/m o 35-40 yr; height adjusted TLV > 2.5 L/m o 40-45 years; height adjusted TLV > 3.0 L/m OR Age independent hTLV > 2.0 L/m and PLD-Q score >
- •With regard to the use of somatostatin analogues: o patients use a somatostatin analogue and still have confirmed liver growth; OR o patient have a reason not to use this medication, .e.g. patient used a somatostatin analogue in the past but had to stop due to inefficacy or because he/she did not tolerate it, patient has a contra-indication for using somatostatin analogues, patient or treating physician chose not to try 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.
- •Diagnosis of polycystic liver disease defined as the presence of more than 10 liver cysts
排除标准
- •Post-menopausal status or (vasomotor) symptoms indicating upcoming menopause
- •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.
- •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), unexplained vaginal bleeding, 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 both MRI and CT assessments (such as implants) or not able or willing to undergo MRI and CT 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
- •Therapy resistant severe hypertension, defined as a systolic blood pressure >160 mmHg and/or diastolic blood pressure > 100 mm Hg.
结局指标
主要结局
The primary outcome variable is liver growth rate (in % per year), calculated over the first 18 months of the trial (screening-18 months) based on liver volumes measured on MRI, comparing the direct start group and delayed start group.
The primary outcome variable is liver growth rate (in % per year), calculated over the first 18 months of the trial (screening-18 months) based on liver volumes measured on MRI, comparing the direct start group and delayed start group.
次要结局
- Polycystic liver disease related complaints, using the validated PLD Questionnaire. The change in the score on the PLD Questionnaire will be compared between patients in the direct start group and the delayed start group after 18 months of treatment.
- Liver growth rate (in % per year) compared within individuals before start of treatment and during treatment.
- (Severe) Adverse events
研究者
R.T. Gansevoort
Scientific
Universitair Medisch Centrum Groningen
研究点 (2)
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