The rationale and study design of two phase II trials examining the effects of BI 685,509, a soluble guanylyl cyclase activator, on clinically significant portal hypertension in patients with compensated cirrhosis

DiscussionThese trials will enable the assessment of the short-term (8  weeks) and longer-term (24 weeks) effects and safety of sGC activation by BI 685,509 on CSPH due to various cirrhosis aetiologies. The trials will use central readings of the diagnostic gold standard HVPG for the primary endpoint, as well as changes in established non-invasive biomarkers, such as liver and spleen stiffness. Ultimately, these trials will provide key information for developing future phase III trials.Trial registration1366.0021: EudraCT no. 2021 –001,285-38; ClinicalTrials.gov NCT05161481. Registered on 17 December 2021,https://www.clinicaltrials.gov/ct2/show/NCT05161481.1366.0029: EudraCT no. 2021 –005,171-40; ClinicalTrials.gov NCT05282121. Registered on 16 March 2022,https://www.clinicaltrials.gov/ct2/show/NCT05282121.
Source: Trials - Category: Research Source Type: clinical trials