Portal hypertension
Conditions
Brief summary
The primary endpoint is the percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment.
Detailed description
Occurrence of a response, which is defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment, Occurrence of one or more decompensation events (i.e. ascites, VH, and / or overt HE) during the 8-week treatment period, Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period, Occurrence of discontinuation due to hypotension or syncope during the 8-week treatment period
Interventions
DRUGEMPAGLIFLOZIN
DRUGBI 685509
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of a response, which is defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment, Occurrence of one or more decompensation events (i.e. ascites, VH, and / or overt HE) during the 8-week treatment period, Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period, Occurrence of discontinuation due to hypotension or syncope during the 8-week treatment period | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Romania, Spain
Outcome results
None listed