Registered outcomes17

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

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs)	From first dose of study drug to 30 days post last dose	Safety and tolerability will be assessed by occurrence of TEAEs. Outcome will be reported as the count of participant experiencing TEAEs.
Primary	Safety Evaluation Criteria - Change in Weight	Change from screening through Day 30	Safety and tolerability will be assessed by change in body weight
Primary	Safety Evaluation Criteria - Vital Signs - Respiration Rate	Change from screening through Day 30	Safety and tolerability will be assessed by change in respiration rate
Primary	Safety Evaluation Criteria - Vital Signs - Body Temperature	Change from screening through Day 30	Safety and tolerability will be assessed by change in body temperature
Primary	Safety Evaluation Criteria - Vital Signs - Continuous pulse oximetry (SpO2)	Change from baseline through Day 30	Safety and tolerability will be assessed by change in SpO2
Primary	Safety Evaluation Criteria - Vital Signs - Systolic Blood Pressure (SBP)	Change from screening through Day 30	Safety and tolerability will be assessed by change in SBP
Primary	Safety Evaluation Criteria - Vital Signs - Diastolic Blood pressure (DBP)	Change from screening through Day 30	Safety and tolerability will be assessed by change in DBP
Primary	Safety Evaluation Criteria - Vital Signs - Heart Rate (HR)	Change from screening through Day 30	Safety and tolerability will be assessed by change in Heart Rate (HR)
Primary	Safety Evaluation Criteria - ECGs - PR interval	Change from screening to Day 14 or hospital discharge	Safety and tolerability will be assessed by occurrence of ECGs
Primary	Safety Evaluation Criteria - ECGs - RR interval	Change from screening to Day 14 or hospital discharge	Safety and tolerability will be assessed by occurrence of ECGs
Primary	Safety Evaluation Criteria - ECGs - QRS duration	Change from screening to Day 14 or hospital discharge	Safety and tolerability will be assessed by occurrence of ECGs
Primary	Safety Evaluation Criteria - ECGs - QT interval	Change from screening to Day 14 or hospital discharge	Safety and tolerability will be assessed by occurrence of ECGs
Primary	Safety Evaluation Criteria - ECGs - QTcF interval	Change from screening to Day 14 or hospital discharge	Safety and tolerability will be assessed by occurrence of ECGs
Primary	Safety Evaluation Criteria - ECGs - QTcB interval	Change from screening to Day 14 or hospital discharge	Safety and tolerability will be assessed by occurrence of ECGs
Primary	The incidence of Responders	90 days	The incidence of Responders (Established HRS reversal defined as patients with a Full or Partial HRS response (based on SCr/AKI stage) AND are alive without Renal Replacement Therapy (RRT) for at least 30 days after the first dose of study medication), evaluated separately as two different outcome groups and combined. In case of recurrence and retreatment during the first 30 days, the second treatment period will be evaluated for response
Secondary	Mortality Rate	30, 60, 90 days	Number of patients who died at day 30, 60, and 90.
Secondary	Liver Transplant Rates	30, 60, 90 days	Number of patients undergoing a liver transplant at day 30, 60, and 90.

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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