EUCTR2021-001285-38-IT进行中（未招募）1 期
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 -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 150 人开始时间: 2021年9月27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
- 150
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 ICHGCP
- •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
- •- 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
- •- 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
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