NL-OMON53952尚未招募2 期
Randomised, open-label and parallel group trial to investigate the effects of oral BI 685509 alone or in combination with empagliflozin on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis. - Investigate BI685509 with/without empagliflozin in patients with CSPH.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed and dated written informed consent in accordance with ICH-GCP and
- •local legislation prior to admission to the trial
- •2. 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 (Visit 1a)
- •3. Clinical signs of CSPH as described by either one of the points below. Each
- •trial patient must have a gastroscopy during the screening period (Visit 1b) or
- •within 6 months prior to screening (Visit 1b).
- •documented endoscopic proof of oesophageal varices and / or gastric varices
- •at screening (Visit 1b) or within 6 months prior to screening (Visit 1b)
- •documented endoscopic-treated oesophageal varices as preventative treatment
- •4. CSPH defined as baseline HVPG >= 10 mmHg (measured at Visit 1c), based on a
- •local interpretation of the pressure tracing
- •5. Diagnosis of compensated cirrhosis due to HCV, HBV, or NASH with or without
- •T2DM. Diagnosis of cirrhosis 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 etc.)
- •Diagnosis of NASH based on either
- •Current or historic histological diagnosis of NASH OR steatosis
- •Clinical diagnosis of NASH based on historic or current imaging
- •diagnosis of fatty liver (Fibroscan, US, MRI, CT) AND at least 2
- •current or historic comorbidities of the metabolic syndrome
- •(overweight/obesity, T2DM, hypertension, hyperlipidemia)
- •6. Willing and able to undergo HVPG measurements per protocol (based on
- •Investigator judgement)
- •7. If receiving statins must be on a stable dose for at least 3 months prior to
- •screening (Visit 1b), with no planned dose change throughout the trial
- •8. If receiving treatment with NSBBs or carvedilol must be on a stable dose for
- •at least 1 month prior to screening (Visit 1b), with no planned dose change
- •throughout the trial
- •9. If receiving pioglitazone, GLP1-agonists, or vitamin E must be on a stable
- •dose for at least 3 months prior to screening (Visit 1b), with no planned dose
- •change throughout the trial
- •10. 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 (Visit
- •2) until 7 days after the last treatment in this trial. The patient must agree
- •to periodic pregnancy testing during participation in the trial.
- •11. 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 (Visit
- •2) until 7 days after the last treatment in this trial.
排除标准
- •1. Previous clinically significant decompensation events (e.g. ascites [more
- •than perihepatic ascites], VH and / or overt / apparent HE)
- •2. History of other forms of chronic liver disease (e.g. alcohol-related liver
- •disease (ARLD), autoimmune liver disease, primary biliary sclerosis, primary
- •sclerosing cholangitis, Wilson*s disease, haemachromatosis, alpha-1 antitrypsin
- •[A1At] deficiency)
- •3. Patients without adequate treatment for HBV, HCV or NASH as per local
- •guidance (e.g. antiviral therapy for chronic HBV or HCV infection or lifestyle
- •modification in NASH)
- •if received curative anti-viral therapy for HCV, no sustained virological
- •response (SVR) or SVR sustained for less than 2 years prior to screening or if
- •HCV RNA detectable
- •If receiving anti-viral therapy for HBV, less than 6 months on a stable dose
- •prior to screening, with planned dose change during the trial or HBV DNA
- •Weight change >= 5% within 6 months prior screening
- •4. 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
- •5. SBP < 100 mmHg and DBP < 70 mmHg at screening (Visit 1a)
- •6. Model of End-stage Liver Disease (MELD) score of > 15 at screening (Visit
- •calculated by the central laboratory
- •7. Hepatic impairment defined as a Child-Turcotte-Pugh score >= B8 at screening
- •(Visit 1a),
- •calculated by the site, using central laboratory results
- •8. ALT or AST > 5 times upper limit of normal (ULN) at screening (Visit 1a),
- •measured by
- •the central laboratory
- •9. eGFR (CKD-EPI formula) < 20 mL/min/1.73 m2 at screening (Visit 1a), measured
- •central laboratory
- •10. Alpha-fetoprotein > 50 ng/mL (> 50 µg/L) at screening (Visit 1a), measured
- •central laboratory
- •11. An active infection with SARS-CoV-2 (or who is known to have a positive
- •screening [Visit 1a] until randomisation [Visit 2])
- •12. Prior orthotopic liver transplantation
- •13. Prior or planned TIPS or other porto-systemic bypass procedure
- •14. Known portal vein thrombosis
- •15. History of clinically relevant orthostatic hypotension, fainting spells or
- •blackouts due to
- •hypotension or of unknown origin (based on Investigator judgement)
- •16. QTcF-interval >450 ms in men or >470 ms in women at screening (Visit 1a), a
- •history of long QT syndrome, or concomitant use of therapies with a known risk
- •Torsade de Pointes or planned initiation of such therapies during the trial
- •17. Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes
- •mellitus (e.g.
- •18. Patients at increased risk of ketoacidosis in the opinion of the
- •investigator.
- •19. Contraindication to any of the trial assessments (e.g. poor patient
- •co-operation for
- •gastroscopy, cardiac pacemakers for FibroScan® [if contraindicated based on
- •local market
- 另有 9 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study to test whether BI 685509 alone or in combination with empagliflozin helps people with liver cirrhosis caused by viral hepatitis or non-alcoholic steatohepatitis (NASH) who have high blood pressure in the portal vein (main vessel going to the liver)EUCTR2021-005171-40-ATBoehringer-Ingelheim RCV GmbH & Co KG80
进行中（未招募）
1 期
A study to test whether BI 685509 alone or in combination with empagliflozin helps people with liver cirrhosis caused by viral hepatitis or non-alcoholic steatohepatitis (NASH) who have high blood pressure in the portal vein (main vessel going to the liver)EUCTR2021-005171-40-DKBoehringer Ingelheim B. V.80
进行中（未招募）
1 期
A study to test whether BI 685509 alone or in combination with empagliflozin helps people with liver cirrhosis caused by viral hepatitis or non-alcoholic steatohepatitis (NASH) who have high blood pressure in the portal vein (main vessel going to the liver)EUCTR2021-005171-40-DEBoehringer Ingelheim Pharma GmbH & Co. KG - Clinical Research Germany80
招募中
2 期
A study to test whether BI 685509 alone or in combination with empagliflozin helps people with liver cirrhosis caused by viral hepatitis or non-alcoholic steatohepatitis (NASH) who have high blood pressure in the portal vein (main vessel going to the liver)Patients with CSPH in compensated cirrhosis due to HBV, HCV, and NASH with or without T2DMJPRN-jRCT2031220376Kutsunai Mitsuru5
进行中（未招募）
1 期
A study to test whether BI 685509 alone or in combination with empagliflozin helps people with liver cirrhosis caused by viral hepatitis or non-alcoholic steatohepatitis (NASH) who have high blood pressure in the portal vein (main vessel going to the liver)CTIS2023-504257-12-00Boehringer Ingelheim International GmbH100