Trial · NCT02039219

Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

NCT02039219, Phase 2, Terminated, Naga P. Chalasani; results first posted 2020-01-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH). Trials, record NCT02039219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02039219

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
NCT number: NCT02039219
Status: Terminated
Phases: Phase 2
Enrollment: 19 participants, actual
Lead sponsor: Naga P. Chalasani
Conditions: Alcoholic Hepatitis
Interventions: Placebo, 10 mg Obeticholic Acid (OCA)
First posted: 2014-01-17
Last updated: 2020-01-28
Results first posted: 2020-01-28

Source ClinicalTrials.gov

Registered outcomes17

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

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).

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	MELD Score Mean(SD)	Baseline to 6 weeks (Day 42)	The decrease in MELD score from baseline to Day 42 was -3.4 in the OCA arm, and -2.2 in the placebo arm with an overall P-Value of 0.6170.	units on a scale	MEAN
PRIMARY	Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	Baseline to 6 weeks (Day 42)	Subjects with SAEs not related to OCA	Events	NUMBER
PRIMARY	MELD Score Change From Baseline Mean(SD)	Baseline to 6 weeks (Day 42)		units on a scale	MEAN
SECONDARY	Any SAEs During the Follow-up Phase	Days 42 to 180		Events	NUMBER
SECONDARY	SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases	Baseline to 180 days		Events	NUMBER
SECONDARY	Adverse Events (AEs) During the Treatment and Follow-up Phases	Baseline to 180 days		Event	NUMBER
SECONDARY	Change in MELD Score at 90 and 180 Days	Days 90 and 180		units on a scale	MEAN
SECONDARY	Change in Child-Pugh Score at Day 42, 90 and 180 Days	Days 42, 90 and 180		units on a scale	MEAN
SECONDARY	Percentage of Participants Deceased at Day 42, 90 and 180	Days 42, 90 and 180		percentage of mortality	NUMBER
SECONDARY	Rates of Hospitalization	Baseline to 180 days		Events	NUMBER

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group76

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
MELD Score Mean(SD)	Placebo	Baseline	16.4	Standard Deviation 2.2	units on a scale
MELD Score Mean(SD)	10 mg Obeticholic Acid (OCA)	Baseline	14.9	Standard Deviation 2.4	units on a scale
MELD Score Mean(SD)	Placebo	Day 42	13.9	Standard Deviation 4.6	units on a scale
MELD Score Mean(SD)	10 mg Obeticholic Acid (OCA)	Day 42	11.5	Standard Deviation 6.8	units on a scale
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	Placebo	Not Related	5		Events
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	10 mg Obeticholic Acid (OCA)	Not Related	1		Events
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	Placebo	Unlikely	6		Events
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	10 mg Obeticholic Acid (OCA)	Unlikely	3		Events
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	Placebo	Possible	0		Events
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase	10 mg Obeticholic Acid (OCA)	Possible	0		Events

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment	STARTED	Placebo	11
Treatment	STARTED	10 mg Obeticholic Acid (OCA)	8
Treatment	COMPLETED	Placebo	7
Treatment	COMPLETED	10 mg Obeticholic Acid (OCA)	6
Treatment	NOT COMPLETED	Placebo	4
Treatment	NOT COMPLETED	10 mg Obeticholic Acid (OCA)	2
Follow up	STARTED	Placebo	7
Follow up	STARTED	10 mg Obeticholic Acid (OCA)	6
Follow up	COMPLETED	Placebo	7
Follow up	COMPLETED	10 mg Obeticholic Acid (OCA)	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events170

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal distension	Gastrointestinal disorders	Placebo	0	11	0
other	Abdominal distension	Gastrointestinal disorders	10 mg Obeticholic Acid (OCA)	1	8	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	11	1
other	Abdominal pain	Gastrointestinal disorders	10 mg Obeticholic Acid (OCA)	2	8	2
other	Weigh Loss	Metabolism and nutrition disorders	Placebo	1	11	1
other	Weigh Loss	Metabolism and nutrition disorders	10 mg Obeticholic Acid (OCA)	0	8	0
other	Accidental overdose	Injury, poisoning and procedural complications	Placebo	0	11	0
other	Accidental overdose	Injury, poisoning and procedural complications	10 mg Obeticholic Acid (OCA)	1	8	1
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	11	1
other	Anaemia	Blood and lymphatic system disorders	10 mg Obeticholic Acid (OCA)	0	8	0

1 to 10 of 170Source ClinicalTrials.gov

See all 170 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	11
Total, all-cause mortality	10 mg Obeticholic Acid (OCA)	0	8
Total, other adverse events	Placebo	9	11
Total, other adverse events	10 mg Obeticholic Acid (OCA)	8	8
Total, serious adverse events	Placebo	5	11
Total, serious adverse events	10 mg Obeticholic Acid (OCA)	6	8

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants4

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01AA021840	Integrated therapies for alcohol use and ALD (ITAALD) Network - IU Clinical Center	CHALASANI, NAGA P; OJO, OLAWALE	INDIANA UNIVERSITY INDIANAPOLIS	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2012 to 2025	NIH RePORTER
U01AA021788	Liquid biopsy for alcoholic hepatitis: diagnosis, prognosis and technology development	SHAH, VIJAY H.; MALHI, HARMEET	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2012 to 2022	NIH RePORTER
U01AA021883	Translational Research and Evolving Alcoholic hepatitis Treatment (TREAT-ADMIN)	CRABB, DAVID W	INDIANA UNIVERSITY INDIANAPOLIS	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2012 to 2017	NIH RePORTER
U01AA021891	TREAT-VCU	SANYAL, ARUN J	VIRGINIA COMMONWEALTH UNIVERSITY	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2012 to 2017	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
10 mg Obeticholic Acid (OCA) vs Placebo: deaths from any cause	Trial comparisons
10 mg Obeticholic Acid (OCA) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02039219

GET https://conductscience.org/api/trials/v1/NCT02039219/results?page=2

API reference For AI assistants