EUCTR2018-002088-25-ES进行中（未招募）1 期
A Phase II, Single-arm, Open-Label Study to Characterise the Effect on Portal Pressure, the Effect on Renal Function and the Pharmacokinetic Profile of N-003 in Patients with Decompensated Cirrhosis
oorik Biopharmaceuticals AG0 个研究点目标入组 24 人开始时间: 2018年11月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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.Signed informed consent including data protection declaration prior to study participation
- •2.Subjects with confirmed cirrhosis (by biopsy, ultrasound, and/or laboratory examinations)
- •3.Ascites Grade II or Grade III at screening
- •4.Currently treated with at least one diuretic or the subject is considered intolerant to diuretics in the investigator’s opinion
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1.Age <18 years of age
- •2.Any of the following laboratory findings at the time of screening
- •a.Serum creatinine level >1.5mg/dL (>132 µmol/L)
- •b.Serum Na+ < 125 meq/L
- •c.Serum K+ = 5.5 meq/L
- •d.Serum bilirubin = 5 mg/dL (85.5 µmol/L)
- •e.INR >3.0
- •3.Women of childbearing potential with no effective contraceptive method (women of childbearing potential [pre-menopausal, not surgically sterile for at least 3 months prior to the time of screening] must have a confirmed negative serum ß-hCG pregnancy test prior to enrolment and at Baseline Visit. They must use an effective contraceptive method throughout the study, and agree to repeat serum ß-hCG pregnancy tests at designated visits)
- •4.Pregnancy or lactation
- •5.Systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg
- •6.Sepsis and/or uncontrolled bacterial infection
- •7.Current or recent documented nephrotoxicity (within 4 weeks)
- •8.Hepatic Encephalopathy above grade 1
- •9.History of variceal bleeding in the last 2 months
- •10.Suspicion of active alcohol consumption in the last 3 months
- •11.History of liver or kidney transplantation
- •12.History of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- •13.Suspected occlusive portal vein or splenic vein thrombosis
- •14.Hepatocellular carcinoma (HCC) beyond the Milan criteria
- •15.Acute Liver Failure or superimposed acute liver injury due to drugs (e.g., acetaminophen), dietary supplements, herbal preparations, viral hepatitis, or toxins
- •16.Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary oedema, congestive heart failure
- •17.Current or recent (within 30 days) renal replacement therapy (RRT)
- •18.If on beta-blockers, a change in dose or drug within last 15 days prior to screening
- •19.Use of any other endothelin receptor antagonist, octreotide, midodrine, terlipressin in last 15 days prior to screening
- •20.Known hypersensitivity to contrast-media
- •21.Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrains the assessment of efficacy
- •22.Known sensitivity to ambrisentan or any of the excipients of the formulation
- •23.Participation in other clinical research involving investigational medicinal products within 30 days of enrolment
- •24.Subjects who have difficulties in understanding the language in which the study information is given
- •25.Subjects who do not agree to the transmission of their anonymous data within the liability of documentation and notification
- •26.Staff of the study centre, staff of the sponsor or CRO, the investigator himself or close relatives of the investigator.
- •Cardiac and Pulmonary Haemodynamic Study exclusion Criteria: Subjects fulfilling any of the exclusion criteria below may participate in the study, but will not undergo cardiac and pulmonary catheterisation:
- •1.Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate < 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of > 90 beats per minute at rest, or Long QT syndrome or QTc > 450 ms
- •2.Significant left ventricular outflow tract obstructions (e.g., severe valvular aortic stenosis, obstructive cardiomyopathy), severe mitral stenosis, restrictive amyloid myocardiopathy, acute myocarditis
- •3.Severe aortic insufficiency or severe mitral r
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