NL-OMON50796招募中2 期
A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease - AGAINST-PLD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
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
- 年龄范围
- 18 至 64（—）
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)
- •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
- •Age independent hTLV > 2.0 L/m and PLD-Q score >30.
- •- With regard to the use of somatostatin analogues:
- •o patients use a somatostatin analogue and still have confirmed liver growth;
- •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.
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), 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.
- •- 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.
研究者
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