A study investigating whether two different doses of BI 685509 can help people with liver cirrhosis and portal hypertension (the main vessel leading to the liver)

Argentina, Austria, Belgium, Canada, China, Croatia, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Romania, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT05161481 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)

Titolo accademico
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 (ICTRP)

Titolo pubblico
A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) (ICTRP)

Malattie studiate
Hypertension, Portal (ICTRP)

Intervento studiato
Drug: Avenciguat (BI 685509)Drug: Placebo matching Avenciguat (BI 685509) (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

1. Signed and dated written informed consent in accordance with International Council
on Harmonisation-Good Clinical Practice (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

3. Clinical signs of Clinically Significant Portal Hypertension (CSPH) as described by
either one of the points below. Each trial patient must have a gastroscopy during
the screening period or within 6 months prior to screening.

- documented endoscopic proof of oesophageal varices and / or gastric varices at
screening or within 6 months prior to screening

- documented endoscopic-treated oesophageal varices as preventative treatment

4. CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) = 10 mmHg, based on
a local interpretation of the pressure tracing

5. 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 10^9/L [150 x 10^3/L], nodular liver surface on imaging or
splenomegaly)

6. Abstinence from significant alcohol misuse / abuse for a minimum of 2 months prior
to screening, and the ability to abstain from alcohol throughout the trial (both
evaluated based on Investigator judgement)

7. Willing and able to undergo HVPG measurements per protocol (based on Investigator
judgement)

8. 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 Further inclusion
criteria apply.

Exclusion Criteria:

1. Previous clinically significant decompensation events (e.g. ascites [more than
perihepatic ascites], Variceal Haemorrhage (VH) and / or apparent Hepatic
Encephalopathy (HE))

2. History of other forms of chronic liver disease (e.g. non-alcoholic steatohepatitis
(NASH), Hepatitis B virus (HBV), untreated Hepatitis C Virus (HCV), autoimmune liver
disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's
disease, haemachromatosis, alpha-1 antitrypsin (A1At) deficiency)

3. Has received curative anti-viral therapy with direct-acting anti-virals within the
last 2 years for HCV, or, if such treatment was > 2 years ago and there is no
sustained virological response (SVR) at screening, or, must take curative anti-viral
therapy with direct-acting anti-virals throughout the trial

4. Alcohol-Related Liver Disease (ARLD) without adequate treatment (e.g. lifestyle
modification) or with ongoing pathological drinking behaviour (misuse / abuse based
on Investigator judgement)

5. 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

6. Systolic Blood Pressure (SBP) < 100 mmHg and Diastolic Blood Pressure (DBP) < 70
mmHg at screening

7. Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated by
the central laboratory

8. Hepatic impairment defined as a Child-Turcotte-Pugh score = B8 at screening,
calculated by the site, using central laboratory results Further exclusion criteria
apply. (ICTRP)

non disponibile

Endpoint primari e secondari
Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline After 24 Weeks of Treatment (ICTRP)

Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline, Measured in Millimeters of Mercury (mmHg), After 8 Weeks of Treatment;Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment;Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 24 Weeks of Treatment;Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 24 Week Treatment Period;Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the First 8 Weeks of the Treatment Period;Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the 24 Week Treatment Period;Occurrence of Discontinuation Due to Hypotension or Syncope During the First 8 Weeks of the Treatment Period;Occurrence of Discontinuation Due to Hypotension or Syncope During the 24 Week Treatment Period (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Boehringer Ingelheim, clintriage.rdg@boehringer-ingelheim.com, 1-800-243-0127 (ICTRP)

ID secondari
2021-001285-38, 1366-0021 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05161481 (ICTRP)