Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Mean change in Hepatic Vein Pressure Gradient (HVPG) from Baseline to Day 14	14 Days	Baseline HVPG is defined as the HVPG assessment performed prior to the first study drug administration. Day 14 HVPG is defined as the HVPG assessment prior to the last dose of study drug. The mean change in HVPG will be calculated as the difference between the HVPG assessment performed at Day 14 and the HVPG assessment performed at baseline
Secondary	Change in 24-hour Urinary Sodium Volume (UNaV)	48 hours	The change in 24-hour Urinary Sodium Volume (UNaV) will be calculated as the difference in 24-hour UNaV at Baseline and the 24-hour UNaV at Day 1 (after the first study drug administration). Urinary sodium volume collected in the 24 hours of baseline will be compared to the Urinary sodium volume collected in the 24 hours after the first dose of the drug. Collection of urine will be ongoing for 48 hours in total.
Secondary	Change in weight	28 days	The change in weight will be calculated as the difference in weight at baseline and weight recorded throughout the study
Secondary	Change in abdominal girth	28 days	The change in abdominal girth will be calculated as the difference in abdominal girth at baseline and abdominal girth recorded throughout the study
Secondary	Change in Model of End-Stage Liver Disease (MELD) score	28 days	The change in MELD score will be calculated as the difference in MELD score at baseline and the MELD scores recorded throughout the study. The MELD score is calculated according to the following formula: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43 The MELD score provides an indication of the anticipated mortality observed in previous studies when subjects were followed for 3-months, according to the following ranges: 71.3% mortality if score is 40 points or more 52.6% mortality if score between 30-39 points 19.6% mortality if score between 20-29 points 6.0% mortality if score between 10-19 points 1.9% mortality if score 9 points or less The MELD score will be calculated at each visit during a 28 day period.
Secondary	Change in Child-Pugh score	28 days	The change in Child-Pugh score will be calculated as the difference in Child-Pugh score at baseline and the Child-Pugh scores recorded throughout the study The Child-Pugh score provides information on the prognosis of a patient based on 5 clinical parameters which are individually graded. These parameters include laboratory values and other clinical information from the patient, such as the presence of ascites or hepatic encephalopathy. A lower score signifies a better chance and a higher score indicates a worse chance of survival at one year. Once the score is calculated it is further subclassified into three stages, depending on the score: Child A - the score is between 5 and 6. The survival rate is 100% Child B - the score is between 7 and 9. The survival rate is 80% Child C - the score is between 10 and 15. The survival rate is 45%
Secondary	Change in Cardiac Output	14 days	The change in Cardiac Output will be calculated as the difference in Cardiac Output at baseline and the Cardiac Output recorded at Day 14
Secondary	Change in Cardiac Index	14 days	The change in Cardiac Index will be calculated as the difference in Cardiac Index at baseline and the Cardiac Index recorded at Day 14
Secondary	Change in Pulmonary Capillary Wedge Pressure	14 days	The change in Pulmonary Capillary Wedge Pressure will be calculated as the difference in Pulmonary Capillary Wedge Pressure at baseline and the Pulmonary Capillary Wedge Pressure recorded at Day 14
Secondary	Change in Pulmonary Arterial Pressure	14 days	The change in Pulmonary Arterial Pressure will be calculated as the difference in Pulmonary Arterial Pressure at baseline and the Pulmonary Arterial Pressure recorded at Day 14
Secondary	Change in Central Venous Pressure	14 days	The change in Central Venous Pressure will be calculated as the difference in Central Venous Pressure at baseline and the Central Venous Pressure recorded at Day 14
Other	Proportion of patients achieving a 20% reduction in HVPG at Day 14 from baseline	14 days
Other	Proportion of patients achieving a 10% reduction in HVPG at Day 14 from baseline	14 days
Other	Proportion of patients achieving an HVPG of 10 mmHg or less at Day 14 from baseline	14 days
Other	Proportion of patients achieving an HVPG of 12 mmHg or less at Day 14 from baseline	14 days

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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