Alcoholic Hepatitis
Conditions
Brief summary
The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.
Interventions
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
DRUGPlacebo
1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Intercept Pharmaceuticals
Naga P. Chalasani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals ≥ 21 years with a diagnosis of acute AH. The diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. A liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of AH cannot be made on clinical and laboratory criteria * Moderate severity defined as MELD score \> 11 and \< 20 * Heavy alcohol consumption (defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment) * Written informed consent * Negative urine pregnancy test where appropriate * Women of child bearing potential should be willing to practice contraception throughout the treatment period
Exclusion criteria
* Significant active infection (e.g., sepsis, or spontaneous bacterial peritonitis; SBP). Subjects can be reconsidered after the infection is under control. * Serum creatinine \> 2.5 mg/dL * Must not be receiving systemic steroids \> 1 week at the time of Screening or any experimental medicines for AH * Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable). * Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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). |
| Length of Hospital Stays | Baseline to 180 days | — |
| 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. |
| 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. |
| 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. |
| Discontinuation Rate During the Treatment and Follow-up Phases | Baseline to 180 days | — |
| 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. |
| 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). |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks. | 11 |
| 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. | 8 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow up | Adverse Event | 0 | 1 |
| Treatment | Adverse Event | 0 | 1 |
| Treatment | Death | 1 | 0 |
| Treatment | Lost to Follow-up | 0 | 1 |
| Treatment | Physician Decision | 1 | 0 |
| Treatment | Protocol Violation | 1 | 0 |
| Treatment | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | 10 mg Obeticholic Acid (OCA) | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 19 Participants | 11 Participants |
| Age, Continuous | 50.375 Years STANDARD_DEVIATION 14.83 | 49.26 Years STANDARD_DEVIATION 11.74 | 48.45 Years STANDARD_DEVIATION 9.61 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 9 Participants |
| Region of Enrollment United States | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 13 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 0 / 8 |
| other Total, other adverse events | 9 / 11 | 8 / 8 |
| serious Total, serious adverse events | 5 / 11 | 6 / 8 |
Outcome results
Primary
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Time frame: Baseline to 6 weeks (Day 42)
Population: Subjects with SAEs not related to OCA
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Unlikely | 6 Events |
| Placebo | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Probable | 0 Events |
| Placebo | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Possible | 0 Events |
| Placebo | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Definite | 0 Events |
| Placebo | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Not Related | 5 Events |
| 10 mg Obeticholic Acid (OCA) | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Definite | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Not Related | 1 Events |
| 10 mg Obeticholic Acid (OCA) | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Unlikely | 3 Events |
| 10 mg Obeticholic Acid (OCA) | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Possible | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Probable | 0 Events |
Primary
MELD Score Change From Baseline Mean(SD)
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.
Time frame: Baseline to 6 weeks (Day 42)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | MELD Score Change From Baseline Mean(SD) | -2.2 units on a scale | Standard Deviation 3.9 |
| 10 mg Obeticholic Acid (OCA) | MELD Score Change From Baseline Mean(SD) | -3.4 units on a scale | Standard Deviation 5.9 |
Primary
MELD Score Mean(SD)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | MELD Score Mean(SD) | Baseline | 16.4 units on a scale | Standard Deviation 2.2 |
| Placebo | MELD Score Mean(SD) | Day 42 | 13.9 units on a scale | Standard Deviation 4.6 |
| 10 mg Obeticholic Acid (OCA) | MELD Score Mean(SD) | Baseline | 14.9 units on a scale | Standard Deviation 2.4 |
| 10 mg Obeticholic Acid (OCA) | MELD Score Mean(SD) | Day 42 | 11.5 units on a scale | Standard Deviation 6.8 |
Comparison: Baselinep-value: 0.1758t-test, 2 sided
Comparison: Day 42p-value: 0.3839t-test, 2 sided
Secondary
Adverse Events (AEs) During the Treatment and Follow-up Phases
Number of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Time frame: Baseline to 180 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Adverse Events (AEs) During the Treatment and Follow-up Phases | Definite | 0 Event |
| Placebo | Adverse Events (AEs) During the Treatment and Follow-up Phases | Not Related | 30 Event |
| Placebo | Adverse Events (AEs) During the Treatment and Follow-up Phases | Unlikely | 17 Event |
| Placebo | Adverse Events (AEs) During the Treatment and Follow-up Phases | Possible | 3 Event |
| Placebo | Adverse Events (AEs) During the Treatment and Follow-up Phases | Probable | 0 Event |
| 10 mg Obeticholic Acid (OCA) | Adverse Events (AEs) During the Treatment and Follow-up Phases | Probable | 1 Event |
| 10 mg Obeticholic Acid (OCA) | Adverse Events (AEs) During the Treatment and Follow-up Phases | Possible | 3 Event |
| 10 mg Obeticholic Acid (OCA) | Adverse Events (AEs) During the Treatment and Follow-up Phases | Not Related | 31 Event |
| 10 mg Obeticholic Acid (OCA) | Adverse Events (AEs) During the Treatment and Follow-up Phases | Definite | 0 Event |
| 10 mg Obeticholic Acid (OCA) | Adverse Events (AEs) During the Treatment and Follow-up Phases | Unlikely | 25 Event |
Secondary
Any SAEs During the Follow-up Phase
Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Time frame: Days 42 to 180
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Any SAEs During the Follow-up Phase | Unlikely | 3 Events |
| Placebo | Any SAEs During the Follow-up Phase | Probable | 0 Events |
| Placebo | Any SAEs During the Follow-up Phase | Possible | 0 Events |
| Placebo | Any SAEs During the Follow-up Phase | Definite | 0 Events |
| Placebo | Any SAEs During the Follow-up Phase | Not Related | 5 Events |
| 10 mg Obeticholic Acid (OCA) | Any SAEs During the Follow-up Phase | Definite | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Any SAEs During the Follow-up Phase | Not Related | 5 Events |
| 10 mg Obeticholic Acid (OCA) | Any SAEs During the Follow-up Phase | Unlikely | 1 Events |
| 10 mg Obeticholic Acid (OCA) | Any SAEs During the Follow-up Phase | Possible | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Any SAEs During the Follow-up Phase | Probable | 0 Events |
Secondary
Change in Child-Pugh Score at Day 42, 90 and 180 Days
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.
Time frame: Days 42, 90 and 180
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Child-Pugh Score at Day 42, 90 and 180 Days | Day 42 | -1.6 units on a scale | Standard Deviation 1.9 |
| Placebo | Change in Child-Pugh Score at Day 42, 90 and 180 Days | Day 90 | -3.0 units on a scale | Standard Deviation 1.2 |
| Placebo | Change in Child-Pugh Score at Day 42, 90 and 180 Days | Day 180 | -2.3 units on a scale | Standard Deviation 3 |
| 10 mg Obeticholic Acid (OCA) | Change in Child-Pugh Score at Day 42, 90 and 180 Days | Day 42 | -2.8 units on a scale | Standard Deviation 1.7 |
| 10 mg Obeticholic Acid (OCA) | Change in Child-Pugh Score at Day 42, 90 and 180 Days | Day 90 | -3.0 units on a scale | Standard Deviation 0.6 |
| 10 mg Obeticholic Acid (OCA) | Change in Child-Pugh Score at Day 42, 90 and 180 Days | Day 180 | -3.5 units on a scale | Standard Deviation 0.8 |
Secondary
Change in MELD Score at 90 and 180 Days
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.
Time frame: Days 90 and 180
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in MELD Score at 90 and 180 Days | Day 90 | -4.4 units on a scale | Standard Deviation 2.8 |
| Placebo | Change in MELD Score at 90 and 180 Days | Day 180 | -4.0 units on a scale | Standard Deviation 5.9 |
| 10 mg Obeticholic Acid (OCA) | Change in MELD Score at 90 and 180 Days | Day 180 | -4.5 units on a scale | Standard Deviation 2.3 |
| 10 mg Obeticholic Acid (OCA) | Change in MELD Score at 90 and 180 Days | Day 90 | -6.0 units on a scale | Standard Deviation 4 |
Secondary
Changes in Activation of Innate Immunity
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.
Time frame: Baseline to 180 days
Population: 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 Bacterial Translocation
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.
Time frame: Baseline to 180 days
Population: 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
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.
Time frame: Baseline to 180 days
Population: 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 Intestinal Inflammation
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.
Time frame: Baseline to Day 180
Population: 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.
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.
Time frame: Baseline to 180 days
Population: 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
Time frame: Baseline to 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Discontinuation Rate During the Treatment and Follow-up Phases | 4 Events |
| 10 mg Obeticholic Acid (OCA) | Discontinuation Rate During the Treatment and Follow-up Phases | 2 Events |
Secondary
Length of Hospital Stays
Time frame: Baseline to 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Length of Hospital Stays | 1.9 Days | Standard Deviation 3.3 |
| 10 mg Obeticholic Acid (OCA) | Length of Hospital Stays | 2.3 Days | Standard Deviation 2.5 |
p-value: 0.8094t-test, 2 sided
Secondary
Percentage of Participants Deceased at Day 42, 90 and 180
Number of subjects deceased at day 42, 90, and 180.
Time frame: Days 42, 90 and 180
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Deceased at Day 42, 90 and 180 | Day 42 | 9.09 percentage of mortality |
| Placebo | Percentage of Participants Deceased at Day 42, 90 and 180 | Day 90 | 9.09 percentage of mortality |
| Placebo | Percentage of Participants Deceased at Day 42, 90 and 180 | Day 180 | 9.09 percentage of mortality |
| 10 mg Obeticholic Acid (OCA) | Percentage of Participants Deceased at Day 42, 90 and 180 | Day 180 | 0 percentage of mortality |
| 10 mg Obeticholic Acid (OCA) | Percentage of Participants Deceased at Day 42, 90 and 180 | Day 42 | 0 percentage of mortality |
| 10 mg Obeticholic Acid (OCA) | Percentage of Participants Deceased at Day 42, 90 and 180 | Day 90 | 0 percentage of mortality |
Comparison: Day 42p-value: 0.3938Log Rank
Comparison: Day 90p-value: 0.3938Log Rank
Comparison: Day 180p-value: 0.3938Log Rank
Comparison: Day 42p-value: 0.3938Log Rank
Comparison: Day 90p-value: 0.3938Log Rank
Comparison: Day 180p-value: 0.3938Log Rank
Secondary
Rates of Hospitalization
Number of subjects with one or more hospitalization are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Time frame: Baseline to 180 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Rates of Hospitalization | Probable | 0 Events |
| Placebo | Rates of Hospitalization | Not Related | 4 Events |
| Placebo | Rates of Hospitalization | Definite | 0 Events |
| Placebo | Rates of Hospitalization | Unlikely | 0 Events |
| Placebo | Rates of Hospitalization | Possible | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Rates of Hospitalization | Unlikely | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Rates of Hospitalization | Possible | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Rates of Hospitalization | Probable | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Rates of Hospitalization | Definite | 0 Events |
| 10 mg Obeticholic Acid (OCA) | Rates of Hospitalization | Not Related | 6 Events |
Secondary
SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases
Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
Time frame: Baseline to 180 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Unlikely | 9 Events |
| Placebo | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Probable | 0 Events |
| Placebo | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Possible | 0 Events |
| Placebo | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Definite | 0 Events |
| Placebo | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Not Related | 10 Events |
| 10 mg Obeticholic Acid (OCA) | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Definite | 0 Events |
| 10 mg Obeticholic Acid (OCA) | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Not Related | 6 Events |
| 10 mg Obeticholic Acid (OCA) | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Unlikely | 4 Events |
| 10 mg Obeticholic Acid (OCA) | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Possible | 0 Events |
| 10 mg Obeticholic Acid (OCA) | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Probable | 0 Events |