EUCTR2007-001711-31-BE
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, phase II, dose-titration trial to explore the safety, tolerability, pharmacokinetic profile and efficacy of M0002 in cirrhotic subjects with ascites and hypo- or normonatraemia.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cirrhotic subjects with ascites and hyponatremia
- 发起方
- Movetis NV
- 入组人数
- 18
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female. Female subjects should be postmenopausal: prior oophorectomy,
- •amenorrheic for 12 months or more in the absence of chemotherapy, tamoxifen,
- •toremifene or ovarian suppression and follicle stimulating hormone and plasma
- •estradiol in the postmenopausal range.
- •2\. 18 – 75 years of age inclusive.
- •3\. Subjects with any form of cirrhosis with ascites and who had
- •at least 1 paracentesis of at least 4 liter in the last 6 months.
- •4\. The diagnosis of cirrhosis must be confirmed by clinical findings such as evidence
- •of portal hypertension (prominent abdominal wall veins, oesophageal varices,
- •hypersplenism) and / or abnormal laboratory tests (LFTs, coagulation disorders
排除标准
- •1\. Women of child bearing potential (WOCBP).
- •2\. Alcohol or drug abuse 4 weeks prior to screening and/or positive test at
- •3\. Malignancy.
- •4\. Known renal impairment (serum creatinine \> 2 mg/dL or 24\-h creatinine clearance \< 40 ml/min).
- •5\. Recent infection (e.g. urinary tract infection, bacteremia, pneumonia, cellulitis) requiring treatment with antibiotics (e.g. ciprofloxacin, norfloxicin) within 14 days prior to trial entry. Long term, prophylactic antibiotic use is not excluded.
- •6\. Surgery requiring general anesthesia within 30 days prior to trial entry.
- •7\. Major pulmonary insufficiency.
- •8\. Head trauma in the past 2 weeks.
- •9\. Adrenal insufficiency, active encephalopathy grade II, uncontrolled hypo\- or hyperthyroidism, unstable diabetes.
- •10\. Subjects with spontaneous bacterial peritonitis (confirmed by culture) within 10 days prior to trial drug administration.
结局指标
主要结局
未指定
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