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) incompensated cirrhosis

Kutsunai Mitsuru0 个研究点目标入组 5 人开始时间: 2022年10月14日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 (Visit1a)
•Clinical signs of CSPH as described by either one of the points below:
•a) documented endoscopic proof of oesophageal varices and / or gastric varices at screening (Visit 1b) or within 3 months prior to screening (Visit 1b)
•b) documented endoscopic-treated oesophageal varices as preventative treatment
•CSPH defined as baseline HVPG >= 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing
•Diagnosis of compensated cirrhosis due to HBV, HCV 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 x103/micro L], nodular liver surface on imaging or splenomegaly etc.)
•Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement)
•If receiving statins, NSBBs or carvedilol must be on a stable dose for at least 3 months prior to screening (Visit 1b), with no planned dose change throughout the trial
•If receiving pioglitazone, GLP1-agonists, or vitamin E must be on a stable dose for at least 3 months prior to screening (Visit1b), with no planned dose change throughout the trial

•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. alcoholrelated liver disease, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilsons disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency)
•Patients without adequate treatment for HBV, HCV, or NASH (e.g. antiviral therapy in chronic HBV or HCV or lifestyle modification in NASH)
•SBP < 100 mmHg and DBP < 70 mmHg at screening (Visit 1a)
•Model of End-stage Liver Disease (MELD) score of more than 15 at screening (Visit 1a)
•Hepatic impairment defined as a Child-Turcotte-Pugh score >= B8 at screening (Visit 1a)
•ALT or AST > 5 times upper limit of normal (ULN) at screening (Visit 1a)
•eGFR (CKD-EPI formula) < 20 mL/min/1.73 m2 at screening (Visit 1a)
•Alpha-fetoprotein > 50 ng/mL (> 50 micro g/L) at screening (Visit 1a)
•History of clinically relevant orthostatic hypotension, faintingspells or blackouts due to hypotension or of unknown origin (based on Investigator judgement)
•Current or planned SGLT2i / SGLT-1/2i treatment
•Type 1 Diabetes Mellitus

发起方

Kutsunai Mitsuru