Trial Outcomes & Findings for Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) (NCT NCT02039219)
NCT ID: NCT02039219
Last Updated: 2020-01-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Baseline to 6 weeks (Day 42)
Results posted on
2020-01-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Treatment
STARTED
|
11
|
8
|
|
Treatment
COMPLETED
|
7
|
6
|
|
Treatment
NOT COMPLETED
|
4
|
2
|
|
Follow up
STARTED
|
7
|
6
|
|
Follow up
COMPLETED
|
7
|
5
|
|
Follow up
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Treatment
Withdrawal by Subject
|
1
|
0
|
|
Treatment
Adverse Event
|
0
|
1
|
|
Treatment
Physician Decision
|
1
|
0
|
|
Treatment
Lost to Follow-up
|
0
|
1
|
|
Treatment
Protocol Violation
|
1
|
0
|
|
Treatment
Death
|
1
|
0
|
|
Follow up
Adverse Event
|
0
|
1
|
Baseline Characteristics
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.45 Years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
50.375 Years
STANDARD_DEVIATION 14.83 • n=7 Participants
|
49.26 Years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Day 42)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
MELD Score Mean(SD)
Baseline
|
16.4 units on a scale
Standard Deviation 2.2
|
14.9 units on a scale
Standard Deviation 2.4
|
|
MELD Score Mean(SD)
Day 42
|
13.9 units on a scale
Standard Deviation 4.6
|
11.5 units on a scale
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Day 42)Population: Subjects with SAEs not related to OCA
Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
Not Related
|
5 Events
|
1 Events
|
|
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
Unlikely
|
6 Events
|
3 Events
|
|
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
Possible
|
0 Events
|
0 Events
|
|
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
Probable
|
0 Events
|
0 Events
|
|
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
Definite
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
MELD Score Change From Baseline Mean(SD)
|
-2.2 units on a scale
Standard Deviation 3.9
|
-3.4 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Days 42 to 180Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Any SAEs During the Follow-up Phase
Unlikely
|
3 Events
|
1 Events
|
|
Any SAEs During the Follow-up Phase
Possible
|
0 Events
|
0 Events
|
|
Any SAEs During the Follow-up Phase
Not Related
|
5 Events
|
5 Events
|
|
Any SAEs During the Follow-up Phase
Probable
|
0 Events
|
0 Events
|
|
Any SAEs During the Follow-up Phase
Definite
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline to 180 daysNumber of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases
Possible
|
0 Events
|
0 Events
|
|
SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases
Probable
|
0 Events
|
0 Events
|
|
SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases
Not Related
|
10 Events
|
6 Events
|
|
SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases
Unlikely
|
9 Events
|
4 Events
|
|
SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases
Definite
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline to 180 daysNumber of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Adverse Events (AEs) During the Treatment and Follow-up Phases
Not Related
|
30 Event
|
31 Event
|
|
Adverse Events (AEs) During the Treatment and Follow-up Phases
Unlikely
|
17 Event
|
25 Event
|
|
Adverse Events (AEs) During the Treatment and Follow-up Phases
Possible
|
3 Event
|
3 Event
|
|
Adverse Events (AEs) During the Treatment and Follow-up Phases
Probable
|
0 Event
|
1 Event
|
|
Adverse Events (AEs) During the Treatment and Follow-up Phases
Definite
|
0 Event
|
0 Event
|
SECONDARY outcome
Timeframe: Days 90 and 180The 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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Change in MELD Score at 90 and 180 Days
Day 90
|
-4.4 units on a scale
Standard Deviation 2.8
|
-6.0 units on a scale
Standard Deviation 4.0
|
|
Change in MELD Score at 90 and 180 Days
Day 180
|
-4.0 units on a scale
Standard Deviation 5.9
|
-4.5 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Days 42, 90 and 180The 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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Change in Child-Pugh Score at Day 42, 90 and 180 Days
Day 42
|
-1.6 units on a scale
Standard Deviation 1.9
|
-2.8 units on a scale
Standard Deviation 1.7
|
|
Change in Child-Pugh Score at Day 42, 90 and 180 Days
Day 90
|
-3.0 units on a scale
Standard Deviation 1.2
|
-3.0 units on a scale
Standard Deviation 0.6
|
|
Change in Child-Pugh Score at Day 42, 90 and 180 Days
Day 180
|
-2.3 units on a scale
Standard Deviation 3.0
|
-3.5 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Days 42, 90 and 180Number of subjects deceased at day 42, 90, and 180.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Percentage of Participants Deceased at Day 42, 90 and 180
Day 42
|
9.09 percentage of mortality
|
0 percentage of mortality
|
|
Percentage of Participants Deceased at Day 42, 90 and 180
Day 90
|
9.09 percentage of mortality
|
0 percentage of mortality
|
|
Percentage of Participants Deceased at Day 42, 90 and 180
Day 180
|
9.09 percentage of mortality
|
0 percentage of mortality
|
SECONDARY outcome
Timeframe: Baseline to 180 daysNumber of subjects with one or more hospitalization are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Rates of Hospitalization
Not Related
|
4 Events
|
6 Events
|
|
Rates of Hospitalization
Unlikely
|
0 Events
|
0 Events
|
|
Rates of Hospitalization
Possible
|
0 Events
|
0 Events
|
|
Rates of Hospitalization
Probable
|
0 Events
|
0 Events
|
|
Rates of Hospitalization
Definite
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline to Day 180Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 180 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 180 daysOutcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Length of Hospital Stays
|
1.9 Days
Standard Deviation 3.3
|
2.3 Days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline to 180 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 180 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 180 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 180 daysOutcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 Participants
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Discontinuation Rate During the Treatment and Follow-up Phases
|
4 Events
|
2 Events
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 9 other events
Deaths: 1 deaths
10 mg Obeticholic Acid (OCA)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=11 participants at risk
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 participants at risk
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Number of events 2 • 6 months
|
0.00%
0/8 • 6 months
|
|
Hepatobiliary disorders
Acute hepatic failure
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
18.2%
2/11 • Number of events 2 • 6 months
|
0.00%
0/8 • 6 months
|
|
Investigations
Blood electrolytes abnormal
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Chronic gastrointestinal bleeding
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Haematemesis
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Psychiatric disorders
Hallucination
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.2%
2/11 • Number of events 2 • 6 months
|
0.00%
0/8 • 6 months
|
|
Investigations
Kidney injury molecule-1
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Psychiatric disorders
Major depression
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/11 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
|
Infections and infestations
Peritonitis bacterial
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Suicidal ideation
|
9.1%
1/11 • Number of events 2 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
|
10 mg Obeticholic Acid (OCA)
n=8 participants at risk
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Weigh Loss
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cholestatic pruritus
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • Number of events 3 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11 • Number of events 3 • 6 months
|
25.0%
2/8 • Number of events 5 • 6 months
|
|
Infections and infestations
Electrocardiogram QT prolonged
|
9.1%
1/11 • Number of events 1 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.3%
3/11 • Number of events 3 • 6 months
|
0.00%
0/8 • 6 months
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
General disorders
Jittery
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • 6 months
|
25.0%
2/8 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • 6 months
|
25.0%
2/8 • Number of events 4 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Renal and urinary disorders
Metabolic acidosis
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Renal and urinary disorders
Micturition urgency
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 2 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • 6 months
|
50.0%
4/8 • Number of events 4 • 6 months
|
|
Investigations
Neutrophil count increased
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
General disorders
Oedema peripheral
|
36.4%
4/11 • Number of events 4 • 6 months
|
50.0%
4/8 • Number of events 5 • 6 months
|
|
Reproductive system and breast disorders
Penile swelling
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Hepatobiliary disorders
Portal hypertension
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • Number of events 3 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Investigations
Pulmonary physical examination abnormal
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • Number of events 2 • 6 months
|
0.00%
0/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Mass
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Swelling
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Vascular disorders
Varices oesophageal
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
Additional Information
Naga Chalasani, MD
Indiana University School of Medicine
Phone: (317) 278-0414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place