EUCTR2006-000134-12-BE进行中（未招募）不适用
Satavaptan in the Prevention of Ascites Recurrence: a double-blind, randomised, parallel-group comparison of satavaptan at 5 to 10 mg daily versus placebo with concomitant diuretics in patients with recurrent ascites due to cirrhosis of the liver - SPARe-1
Sanofi- aventis R&D0 个研究点目标入组 450 人开始时间: 2006年4月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with cirrhosis of the liver confirmed by histology and/or a combination of either ultrasound, CT or endoscopic examination with laboratory evidence (e.g. low platelet count, low serum albumin, elevated total serum bilirubin or elevated INR).
- •- Patients with recurrent ascites having undergone both of the following:
- •. therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of >= 4 litres of fluid,
- •. at least one other therapeutic paracentesis in the previous 3 months.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Related to study methodology
- •Age <18 years
- •No written informed consent
- •Inability to follow verbal and written instructions.
- •Patients with an existing functional TIPS (transjugular intrahepatic portosystemic shunt) or other shunt designed to transfer blood from the portal system to the systemic circulation bypassing the liver.
- •Budd-Chiari syndrome
- •Patients with positive HBV DNA who have started antiviral treatment in the previous 4 weeks or in whom such treatment is planned to start during the next 12 weeks.
- •Previous liver transplantation
- •Known hepatocellular carcinoma (unless only one lesion <5 cm diameter or no more than 3 nodules of <3 cm each).
- •Sepsis or spontaneous bacterial peritonitis currently or in the 10 days before randomisation.
- •Current hepatic encephalopathy (>grade 1 by the West Haven criteria, Appendix B) evaluated by clinical features
- •Known gastrointestinal bleeding currently or in the 10 days before randomisation.
- •QTcF interval on an ECG >= 480 ms.
- •Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
- •Serum bilirubin >150 µmol/l
- •INR >3.0, neutrophils <1 000/mm3, platelets <30 000/mm3.
- •Patients previously exposed to satavaptan in the past 12 months
- •2) Related to satavaptan
- •Haemodynamic insufficiency (systolic arterial pressure <80 mmHg or symptomatic orthostatic hypotension)
- •Serum sodium >143 mmol/l
- •Serum potassium <3.5 mmol/l or >= 5.0 mmol/l
- •Serum magnesium <0.65 mmol/l
- •Significant renal impairment with serum creatinine >150 µmol/l
- •Positive pregnancy test
- •Females of child-bearing potential are excluded unless they meet one of the following criteria:
- •. Post-menopausal for 6 months or more, and if post-menopausal for less than 2 years, a negative pregnancy test
- •. Surgical sterilisation for more than one month duration and a negative pregnancy test
- •. Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test
- •. Oral contraceptive in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test.
- •. Known hypersensitivity to satavaptan
- •Administration of inducers of CYP3A listed below within the two weeks prior to study drug administration:
- •. carbamazepine, phenobarbital, phenytoin, rifampicin (rifampin), Saint John's Wort
- •· Administration of potent and selected moderate inhibitors of CYP3A, which may significantly increase exposure to the study drug within the two weeks prior to study drug administration. These are listed below and in Appendix F:
- •. Aprepitant, atazanavir, chloramphenicol, clarithromycin, cremophor EL, cyclosporin, diltiazem, erythromycin, fluconazole, grapefruit juice, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil, theophylline voriconazole
- •Patients taking other drugs known to increase the risk of hyperkalaemia in addition to spironolactone, potassium canrenoate or eplerenone may not be included in the study in order to avoid an additive effect on serum potassium concentrations (e.g. angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists).
研究者
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