EUCTR2018-002088-25-AT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: 2019年7月25日最近更新:
适应症
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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
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: For subjects enrolled in sites performing cardiac and pulmonary catheterisations, 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
研究者
相似试验
进行中（未招募）
1 期
A Non-Placebo Clinical Trial in Patients with Chronic Liver Disease to Test the Safety and Effect of N-003 on Liver Blood Pressure and Renal Function, as well as N-003 Levels in BloodEUCTR2018-002088-25-ESoorik Biopharmaceuticals AG24
进行中（未招募）
1 期
A study to investigate the safety and the effects of PBI-4050 when given to patients with the rare genetic disorder, Alström SyndromeAlström SyndromeMedDRA version: 19.1 Level: LLT Classification code 10068814 Term: Alstrom syndrome System Organ Class: 100000004850EUCTR2015-001625-16-GBProMetic BioSciences Inc.18
进行中（未招募）
1 期
A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of 100mg Twice Daily Oral Dosing of Midostaurin Administered to Patients with Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease. - NDEUCTR2008-000280-42-ITOVARTIS FARMA116
进行中（未招募）
1 期
A Phase 2 Study of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)EUCTR2017-004288-11-GBADC Therapeutics SA140
进行中（未招募）
1 期
A Phase 2 Study of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)MedDRA version: 20.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004288-11-ITADC THERAPEUTICS SA140