Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of two doses (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 24 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis

SCS Boehringer Ingelheim Comm. V0 个研究点目标入组 150 人开始时间: 2021年9月15日最近更新: 2024年5月27日

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: 150

研究概览入排标准研究者记录与标识符相似试验

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

•- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
•- Male or female who is = 18 (or who is of legal age in countries where that is greater than 18) and = 75 years old at screening
•- Clinical signs of CSPH as described by either one of the points below. Each trial patient must have a gastroscopy during the screening period or within 3 months prior to screening.
•- documented endoscopic proof of oesophageal varices and / or gastric varices at screening or within 3 months prior to screening
•- documented endoscopic-treated oesophageal varices as preventative treatment
•- CSPH defined as baseline HVPG = 10 mmHg, based on a local interpretation of the pressure tracing
•- Diagnosis of compensated alcohol-related cirrhosis. Diagnosis must be based on histology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g. platelet count < 150 x 109/L [150 x 103/µL], nodular liver surface on imaging or splenomegaly)
•- Abstinence from alcohol for a minimum of 6 months prior to screening, which, based on Investigator judgement, can be maintained throughout the trial
•- Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement)
•- If receiving statins must be on a stable dose for at least 3 months prior to screening, with no planned dose change throughout the trial
•- If receiving treatment with NSBBs or carvedilol must be on a stable dose for at least 3 months prior to screening, with no planned dose change throughout the trial
•- WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from the randomisation visit until 7 days after the last treatment in this trial. The patient must agree to periodic pregnancy testing during participation in the trial.
•- Men able to father a child and who have a female sexual partner of CBP, must use a condom with or without spermicide, or adopt complete sexual abstinence, or be vasectomised (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), from the randomisation visit until 7 days after the last treatment in this trial.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

排除标准

•- Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], VH and / or apparent HE)
•- History of other forms of chronic liver disease (e.g. non-alcoholic steatohepatitis [NASH], Hepatitis B virus [HBV], untreated HCV, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson’s disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency)
•- Has received curative anti-viral therapy with direct-acting anti-virals within the last 2 years for HCV with a sustained virological response (SVR) at screening and throughout the trial
•- ARLD without adequate treatment (e.g. lifestyle modification) or with ongoing pathological drinking behaviour
•- Must take, or wishes to continue the intake of, restricted concomitant therapy or any concomitant therapy considered likely (based on Investigator judgement) to interfere with the safe conduct of the trial
•- SBP < 100 mmHg and DBP < 70 mmHg at screening
•- Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated by the central laboratory
•- Hepatic impairment defined as a Child-Turcotte-Pugh score = B8 at screening, calculated by the site, using central laboratory results
•- ALT or AST > 5 times upper limit of normal (ULN) at screening, measured by the central laboratory
•- eGFR (CKD-EPI formula) < 20 mL/min/1.73 m2 at screening, measured by the central laboratory
•- Alpha-fetoprotein > 50 ng/mL (> 50 µg/L) at screening, measured by the central laboratory
•- An active infection with SARS-CoV-2 (or who is known to have a positive test from screening until randomisation)
•- Prior orthotopic liver transplantation
•- Prior or planned TIPS or other porto-systemic bypass procedure
•- Known portal vein thrombosis
•- History of clinically relevant orthostatic hypotension, fainting spells or blackouts due to hypotension or of unknown origin (based on Investigator judgement)
•- Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
•- Further criteria apply

研究者

发起方

SCS Boehringer Ingelheim Comm. V

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