A study to test whether BI 685509 helps people with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver) who had bleeding in the esophagus or fluid accumulation in the belly

JRCT ID: jRCT2031230564

Registered date:12/01/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: CSPH in decompensated liver cirrhosis regardless of the etiology of chronic liver disease
• Date of first enrollment: 31/01/2024
• Target sample size: 40
• Countries of recruitment: Austria,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Italy,Japan,Republic of Korea,Japan,Romania,Japan,Spain,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): BI 685509 and matching placebo

Outcome(s)

• Primary Outcome: Percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment.

Secondary Outcome

1) Occurrence of a response, which is defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment
2) Occurrence of one or more decompensation events (i.e. ascites, variceal haemorrhage [VH], and / or overt hepatic encephalopathy [HE]) during the 8 week treatment period
3) Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8 week treatment period
4) Occurrence of discontinuation due to hypotension or syncope during the 8 week treatment period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 76age old
• Gender: Both

Include criteria

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 equal to or older than 18 (or who is of legal age in countries where that is greater than 18) and is eadual to or younger than 75 years old at screening (Visit 1a)
3. Diagnosis of cirrhosis due to non-cholestatic liver disease (including HCV, HBV, NASH, alcohol-related liver disease, autoimmune hepatitis, Wilsons disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency)
4. One previous clinically significant decompensation event with clinical resolution at least 4 weeks prior start of screening (visit 1a):
a) First variceal haemorrhage
b) First episode of clinically significant ascites (requiring intervention in lifestyle [fluid and salt restriction] or medical treatment)
5.Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement)

Exclude criteria

1.History of cholestatic chronic liver disease (e.g. primary biliary cholangitis, primary sclerosing cholangitis)
2.Trial participants 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)
3.If received curative anti-viral therapy for HCV, SVR sustained for less than 1 years prior to screening
4.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 detectable
5.Weight change more than eaqual to 5 percent within 6 months prior screening in patients with NASH
6.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
7.SBP less than 100 mmHg or DBP less than 70 mmHg at screening (Visit 1a)
8.Hepatic impairment defined as a Child-Turcotte-Pugh score eaqual to or greater than 8 at screening

Related Information

• Primary Sponsor: Taguchi Aya
• Secondary ID(s): NCT06082843