Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02039219
Other study ID # TREAT 002
Secondary ID 1U01AA021840-01U
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 3, 2014
Est. completion date January 29, 2018

Study information

Verified date January 2020
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date January 29, 2018
Est. primary completion date July 30, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

Drug:
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, approximately 30 minutes prior to breakfast for 6 weeks.

Locations

Country Name City State
United States Indiana University Indianapolis Indiana
United States Einstein Healthcare Network Philadelphia Pennsylvania
United States Virgina Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Naga P. Chalasani Intercept Pharmaceuticals, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Baseline to 6 weeks (Day 42)
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). Baseline to 6 weeks (Day 42)
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. Baseline to 6 weeks (Day 42)
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). Days 42 to 180
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). Baseline to 180 days
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). Baseline to 180 days
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. Days 90 and 180
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. Days 42, 90 and 180
Secondary Percentage of Participants Deceased at Day 42, 90 and 180 Number of subjects deceased at day 42, 90, and 180. Days 42, 90 and 180
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). Baseline to 180 days
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. Baseline to Day 180
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. Baseline to 180 days
Secondary Length of Hospital Stays Baseline to 180 days
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. Baseline to 180 days
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. Baseline to 180 days
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. Baseline to 180 days
Secondary Discontinuation Rate During the Treatment and Follow-up Phases Baseline to 180 days
See also
  Status Clinical Trial Phase
Recruiting NCT04066179 - Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients. N/A
Completed NCT03732586 - Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00962442 - N-Acetylcysteine in Severe Acute Alcoholic Hepatitis Phase 3
Not yet recruiting NCT06307522 - MRG-001 in Patients With Alcoholic Hepatitis Phase 2
Recruiting NCT05018481 - HA35 Moderate Alcoholic Hepatitis (AH) Study Early Phase 1
Completed NCT04544020 - Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis)
Recruiting NCT04088370 - Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
Completed NCT04235855 - EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication? N/A
Active, not recruiting NCT02344680 - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed NCT00851981 - Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease Phase 2
Completed NCT04084522 - Effect of Saturated Fat (Desi Ghee) on Gut-Liver Axis in Alcoholic Hepatitis N/A
Completed NCT05840640 - Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis Phase 4
Recruiting NCT03069300 - N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis Phase 3
Completed NCT01245257 - Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis N/A
Completed NCT02019056 - Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis Phase 2
Completed NCT00388323 - Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human N/A
Recruiting NCT03845205 - Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH N/A
Recruiting NCT03703674 - GCSF in Alcoholic Hepatitis Phase 4
Active, not recruiting NCT02473341 - Comparison of Bovine Colostrum Versus Placebo in Treatment of Severe Alcoholic Hepatitis: A Randomized Double Blind Controlled Trial Phase 3