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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Movetis NV
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
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
- •(prolonged coagulation time), low platelet count, anaemia, low albumin, low total
- •protein. The presence of ascites must be documented by ultrasound imaging.
- •Duration since diagnosis should be noted.
- •5. Dose of diuretics of spironolactone and furosemide should be stable for at least
- •one week prior to the screening visit or subject is refractory to diuretics.
- •6. Subjects must have been on a salt restricted diet (< 5.2 grams sodium/day, 90
- •mmol) during the screening period prior to the trial drug administration.
- •7. Subjects (or their legally acceptable representatives) must have read and signed
- •the written informed consent form after the nature of the trial has been fully
- •explained, indicating the subject understands the purpose of and procedures
- •required for the trial and is willing to comply with trial procedures and restrictions.
- •8. Other treatment for the management of cirrhosis and ascites should be stable for
- •at least 2 weeks prior to trial drug administration.
- •9. Child-Pugh B and C (< 12) liver cirrhosis.
- •10.Subjects with hyponatraemia with sodium level between 120 and 132 mmol/L or
- •normonatraemia with sodium level between 133 and 145 mmol/L measured at
- •screening visit and day 1.
- •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) no
- •F.1.3.1 Number of subjects for this age range
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.
- •11. Gastrointestinal bleed within 10 days prior to trial drug administration.
- •12. Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
- •13. Liver transplantation.
- •14. Budd-Chiari syndrome
- •15. Evidence of intravascular hypovolemia or major hemodynamic instability defined as systolic arterial pressure < 80 mm Hg, orthostatic hypotension, and pulse rate > 120 beats per minute.
- •16. Any evidence of active myocardial ischemia, myocardial infarction in the last 6 months.
- •17. Subjects with clinically relevant abnormal ECG intervals of morphology of the ECG, QTc > 480 ms.
- •18. Positive HIV test.
- •19. Hemoglobin < 9 g/dL.
- •20. Unstable hepatic disease (acute hepatitis, AST or ALT > 5 x upper limit of normal, bilirubin > 10 mg/dL)
- •21. Serum potassium > 6.0 mmol/L or < 3 mmol/L, osmolality > 295 mOs/kg.
- •22. Platelet count < 40 x 10³ / mm³.
- •23. Significant coagulopathy such as INR > 2.
- •24. Participation in an investigational drug or device trial within 30 days prior to screening.
- •25. Use of the following therapeutic agents: salt tablets or hypertonic saline, NSAIDs, corticosteroids, anticoagulants, saline solution, vasopressin analogs, DDAVP, lithium, demeclocycline, oncologic agents, drugs with potent CYP 3A4 inhibitors (such as itraconazole, ketoconazole, erythromycin, ritonavir, indinavir, sequinavir, …) or drugs known to affect platelet function within 14 days prior to trial drug administration.
- •26. Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subjects to comply with the trial requirements.
- •27. Any condition that in the opinion of the investigator(s) would complicate or compromise the trial or the well being of the subject or evidence of clinically relevant pathology that could interfere with the trial results or put the subject’s safety at risk.
研究者
相似试验
进行中（未招募）
1 期
A randomized, double blind, placebo controlled, phase II, multi-centre pilot study to investigate the effects of vitamin D2 or D3 supplementation on metabolic parameters in people at risk of type 2 diabetes. - Vitamin D Supplementation in People at Risk of Type 2 Diabetes V1.3EUCTR2009-011264-11-GBQueen Mary University of London340
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 normonatremia.Cirrhotic subjects with ascites and hypo- or normonatraemiaMedDRA version: 9.1Level: LLTClassification code 10009213Term: Cirrhosis of liverMedDRA version: 9.1Level: LLTClassification code 10003445Term: AscitesMedDRA version: 9.1Level: LLTClassification code 10021038Term: HyponatremiaEUCTR2007-001711-31-DEMovetis NV12
进行中（未招募）
1 期
A study investigating the efficacy and safety of 2 doses of NuSepin® intravenous infusion in adult subjects with Covid-19 pneumoniaAdult subjects with Covid-19 pneumoniaEUCTR2020-003107-34-ROShaperon Inc60
已完成
3 期
A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.breast cancerNL-OMON39231ovartis Pharma BV10
进行中（未招募）
不适用
A study of the experimental drug BKM120 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer, with or without PI3K activatioThis study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2011-005932-24-HUovartis Pharma Services AG524