EUCTR2015-004031-12-GB进行中（未招募）1 期
Serelaxin To Lower Portal Pressure in Patients with Cirrhosis and Portal Hypertension (STOPP) - Serelaxin To Lower Portal Pressure (STOPP) study
niversity of Edinburgh0 个研究点目标入组 15 人开始时间: 2018年5月23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
- 15
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 adult subjects over 18 years of age
- •2) Able to provide written informed consent and able to understand and willing to comply with the requirements of the study
- •3) Clinical/imaging-diagnosed or biopsy-proven liver cirrhosis of any aetiology
- •4) Evidence of portal hypertension either on imaging or previous endoscopy
- •5) Patients with large/grade 3 varices as identified by endoscopy within 6 months of screening must be in an endoscopic band ligation programme at the time of study entry
- •6) Suspected hepatic venous pressure gradient (HVPG) =10 mmHg at baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1) Pregnancy or nursing (lactating) women
- •2) Women of child-bearing potential not using highly effective methods of contraception.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire period of the study – until 4 weeks following Visit 2.
- •Further details are found at the following web address: (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01- About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf
- •In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking the investigational drug.
- •Contraception must be continued for up to the end of study – 4 weeks following Visit 2.
- •3) Severe liver failure defined by one of the following: Prothrombin activity < 40%, Bilirubin > 5 mg/dL (85umol/L), hepatic encephalopathy > grade I
- •4) Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
- •5) A history of variceal bleed within 1 month prior to visit 1
- •6) Hepatocellular carcinoma or history of malignancy of any organ system (other than localized basal cell carcinoma of the skin) treated or untreated.
- •7) Portal vein thrombosis
- •8) Previous surgical shunt or TIPSS
- •9) Current use of beta-blockers or nitrates, any other drug therapy known to have an influence on portal pressure (diuretics permitted provided patients have been on a stable dose for at least 30 days)
- •10) History of drug or alcohol abuse within 1 month of enrolment
- •11) Sitting Systolic Blood Pressure <110 mmHg at screening visit or within 10 minutes prior to starting study drug infusion
- •12) Use of other investigational drugs within 5 half-lives of enrolment, or within 30 days/until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •13) 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 msec (QT correction will be performed using the Fridericia correction method: QTcF = QT/RR0.33) for males and > 460 msec for females at screening (visit 1)
- •14) Documented hypersensitivity to intravenous contrast agents and/or iodine
- •15) Severe renal impairment (eGFR<30mL/min /1.73m2)
- •16) Significant left ventricular outflow tract obstructions (e.g., severe valvular aortic stenosis, obstructive cardiomyopathy), severe mitral stenosis, restrictive amyloid myocardiopathy, acute myocarditis
- •17) Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated
- •18) Major neurologic event including cerebrovascular events, within 30 days prior to screening
- •19) Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrolment
- •20) History of hypersensitivity to study drug serelaxin or study drug ingredients
- •21) Inability to follow instructions or comply with follow-up procedures
- •22) Permanent pacemaker, cardiac resynchronisation device or implantable cardioverter-defibrillator in situ
研究者
相似试验
已完成
2 期
Serelaxin To Lower Portal PressureHypertension, PortalLiver CirrhosisNCT02669875University of Edinburgh15
已完成
不适用
Medication induced blood pressure reduction; assessment of cerebral perfusion and cognition in hypertensive elderlyhypertensionhigh blood pressure1000796310057166NL-OMON33986niversitair Medisch Centrum Sint Radboud60
Unknown
2 期
Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic PatientsPortal HypertensionLiver CirrhosisNCT01897051Yonsei University140
Unknown
2 期
Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver ResectionPortal Vein PressureNCT03352349Shanghai Zhongshan Hospital30
尚未招募
不适用
PressureNL-OMON20713afdeling gynaecologie in het Zuyderland20