Sample size {14}
NASH, T2DM, HCV infection, HBV infection
The 1366.0021 trial will enrol 105 patients, randomised 1:1:1 to each dose group. Sample size was calculated based on the probability of observing the estimated treatment effect for mean reduction in HVPG from baseline. It was assumed that the mean reduction in HVPG from baseline at week 24 would be 0%, 23% and 25% for the placebo, moderate and high dose groups, respectively. With a sample size of 35 patients per dose group, there is an 84.8% probability of observing a difference of ≥ 20% reduction in HVPG from baseline between at least one BI 685509 dose group and placebo. An interim analysis will take place after 60 patients (20 per dose group) have completed the first 8 weeks of treatment and the week 8 HVPG measurement. With this sample size, the probability of observing a treatment effect is 87.7%, assuming that the mean reduction in HVPG from baseline will be 0%, 17% and 20% for the placebo, moderate and high dose groups, respectively.The 1366.0029 trial will enrol 80 patients: 20 patients each with HBV infection, HCV infection or NASH receiving BI 685509 monotherapy and 20 patients with NASH and T2DM receiving BI 685509 and empagliflozin. Sample size was calculated based on the probability of observing the estimated treatment effect for mean reduction in HVPG from baseline. With a sample size of 20 patients per treatment group, there is a 96.3% probability of observing a ≥ 10% mean reduction in HVPG from baseline.