EUCTR2020-005949-16-DE招募中1 期
A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease - AGAINST-PLD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
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
- Female
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
- •- 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:
- •o patients use a somatostatin analogue and still have confirmed liver growth; OR
- •o 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.
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Post-menopausal status or (vasomotor) symptoms indicating upcoming menopause
- •2. Anti Mullerian Hormone (AMH) measurement at screening visit <0.03 ng/ml.
- •3. Patients who are pregnant or lactation, or who have an active desire to have children,
- •pregnancy or breast-feeding during the clinical study
- •4. A history of osteoporosis or osteoporosis determined by DEXA-scan at screening (T
- •score = -2.5)
- •5. Patients diagnosed with a clinical depression and is or has been treated with antidepression medication.
- •6. Patients known with a prolongated QT time or who use medicinal products leading to
- •a QT prolongation including, but not restricted to: class IA (e.g. quinidine,
- •disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)
- •antiarrhythmic medicinal products, methadone, moxifloxacin and antipsychotics.
- •7. Hypersensitivity to leuprorelin or other GnRH analogues, to polylactic acid or
- •poly(D,L-lactide-co-glycolide) (1:1)
- •8. Patients with epilepsy which is not well-controlled (defined as manifestation of >= 1
- •seizure in the last 12 months).
- •9. Patients with a confirmed hormone independence carcinoma.
- •10. Liver transplantation or liver surgery expected within 1.5 years, to the discretion of the
- •study doctor
- •11. Use of hormonal oral contra-conception containing estrogen and/or progesterone. In
- •contrast, a hormone containing uterine device is not an exclusion criteria.
- •12. 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)
- •13. Kidney transplantation or chronic use of immunosuppressive agents (such as
- •cyclosporine, mycophenolic acid, tacrolimus but not prednisolone) for other indications
- •14. Severe hypertension, defined as a systolic blood pressure >160 mmHg and/or diastolic
- •blood pressure > 100 mm Hg.
- •15. 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
- •16. Participation in other clinical trials or treatments with other IMPs and its relevant
- •metabolites or previous therapies, whose toxicity (may) overlap with that of this
- •studies IMP and its relevant metabolites within five times the half-life of the drug
- •and/or metabolites (whichever is longer).
- •17. Participation in other interventional studies at the same time.
- •Exclusion criteria related to the historical MRI or CT scan to determine liver
- •growth before start of the study
- •- Start or stop of liver volume reducing therapy (medication e.g. somatostatin analogues
- •or surgical interventions) in the period between the historical scan and the baseline
- •- The historical MRI or CT scan is performed <3 months after start or stop of a
- •somatostatin analogue or surgical volume reducing therapy.
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