Liver cirrhosis with features of portal hypertension.
Conditions
Brief summary
Part A Primary End Point: Absolute change in HVPG from baseline to Week 6., Part B Primary End Point: Absolute change in HVPG from baseline to Week 6
Detailed description
Part A: Percent change in HVPG from baseline to Week 6., Part A: HVPG response, where a responder is defined as HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg from baseline to Week 6., Part A: Evaluation of change in body weight (kg) over time course of study (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6. (Office balance), Part A: Percentage and Absolute change in total change dosage of loopdiuretic equivalents use from baseline to Week 6., Part A: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6. Change in total body fat mass from baseline to Week 6., Part A: Change in systolic and diastolic blood pressure from baseline to Week 6, Part B: Percentage and change in HVPG from baseline to Week 6., Part B: Evaluation of change in body weight (kg) over time course of study. (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6 and Week 16. (Office balance), Part B: Absolute change in total dosage of loop-diuretic equivalents use from baseline to Week 6 and Week 16, Part B: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6 and Week 16. Change in total body fat mass from baseline to Week 6 and Week 16, Part B: Change in systolic and diastolic blood pressure from baseline to Week 6 and Week 16., Part B : To evaluate Part B: HVPG response, where a responder is defined as at least 20% decrease or a reduction to or below 12 mmHg in HVPG from baseline to Week 6.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Primary End Point: Absolute change in HVPG from baseline to Week 6., Part B Primary End Point: Absolute change in HVPG from baseline to Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Percent change in HVPG from baseline to Week 6., Part A: HVPG response, where a responder is defined as HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg from baseline to Week 6., Part A: Evaluation of change in body weight (kg) over time course of study (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6. (Office balance), Part A: Percentage and Absolute change in total change dosage of loopdiuretic equivalents use from baseline to Week 6., Part A: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6. Change in total body fat mass from baseline to Week 6., Part A: Change in systolic and diastolic blood pressure from baseline to Week 6, Part B: Percentage and change in HVPG from baseline to Week 6., Part B: Evaluation of change in body weight (kg) over time course of study. (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6 and Week 16. (Office b | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Netherlands, Romania, Spain