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	MELD Score Mean(SD)	Baseline to 6 weeks (Day 42)	The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Primary	Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	Baseline to 6 weeks (Day 42)	Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Primary	MELD Score Change From Baseline Mean(SD)	Baseline to 6 weeks (Day 42)	The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Secondary	Any SAEs During the Follow-up Phase	Days 42 to 180	Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Secondary	SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases	Baseline to 180 days	Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Secondary	Adverse Events (AEs) During the Treatment and Follow-up Phases	Baseline to 180 days	Number of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Secondary	Change in MELD Score at 90 and 180 Days	Days 90 and 180	The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Secondary	Change in Child-Pugh Score at Day 42, 90 and 180 Days	Days 42, 90 and 180	The Child-Pugh score is a system for assessing the prognosis - including the required strength of treatment and necessity of liver transplant - of chronic liver disease, primarily cirrhosis. It provides a forecast of the increasing severity of your liver disease and your expected survival rate. The Child-Pugh score is determined by scoring five clinical measures of liver disease. A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. The total Child-Pugh range is 5-15, with 15 being the most severe.
Secondary	Percentage of Participants Deceased at Day 42, 90 and 180	Days 42, 90 and 180	Number of subjects deceased at day 42, 90, and 180.
Secondary	Rates of Hospitalization	Baseline to 180 days	Number of subjects with one or more hospitalization are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Secondary	Changes in Intestinal Inflammation	Baseline to Day 180	Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.
Secondary	Changes in Serum Oxidative Stress.	Baseline to 180 days	Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.
Secondary	Length of Hospital Stays	Baseline to 180 days
Secondary	Changes in Bacterial Translocation	Baseline to 180 days	Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.
Secondary	Changes in Cytokines	Baseline to 180 days	Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.
Secondary	Changes in Activation of Innate Immunity	Baseline to 180 days	Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.
Secondary	Discontinuation Rate During the Treatment and Follow-up Phases	Baseline to 180 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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