FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
NCT ID: NCT05639543
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2022-12-15
2027-04-01
Brief Summary
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Detailed Description
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Additionally, PK measurements at various study timepoints will allow the Sponsor to better understand the systemic exposure of INT-787 and the relationship between exposure and efficacy and safety. Such insights in participants with more advanced liver disease will provide valuable information for future clinical trials of INT-787.
The placebo-treated participants will provide important natural history information on outcomes in this participant population with sAH treated with supportive care. The placebo-treated participants within cohorts are meant to blind the study drug administration while the data across dose cohorts will be used in the overall analysis.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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INT-787
Participants will be randomized to receive INT-787 (in Dose Escalation Cohorts \[Cohorts 1 through 4\] and Extension Phase Cohorts \[Cohorts 5 and 6\])
INT-787
Blinded Study Drug
Placebo
Participants will be randomized to receive matching placebo
Placebo
Placebo
Interventions
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INT-787
Blinded Study Drug
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of sAH based on all the following:
1. History of ongoing excess alcohol (\>60 g/day \[male\] or \>40 g/day \[female\]) use for ≥6 months, with \<60 days of abstinence prior to the onset of jaundice
2. Serum total bilirubin \>3.0 mg/dL
3. Aspartate aminotransferase (AST) ≥50 U/L
4. AST/Aspartate aminotransferase (ALT) ratio ≥1.5
5. Onset of jaundice within prior 8 weeks
6. Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70
7. Cohort 5 and Cohort 6: mDF ≥32
3. Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
4. Female participants must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception from the initiation of Screening and for 90 days after the last dose of investigational product as follows:
* Surgical sterilization (bilateral tubal occlusion, etc.)
* Placement of an intrauterine device (IUD) or intrauterine system (e.g., intrauterine hormone-releasing system \[IUS\])
* Combined (estrogen and progesterone containing) hormonal contraceptive associated with inhibition of ovulation:
* Oral
* Intravaginal
* Transdermal
* Progesterone-only hormonal contraception associated with inhibition of ovulation:
* Oral
* Injectable
* Implantable
* Sexual abstinence: When in line with the preferred and usual lifestyle of the participant, is defined as avoiding all types of activity that could result in conception (pregnancy) from the initiation of Screening and until at least 90 days after the last dose of investigational product
6. Male participants must refrain from sperm donation from the initiation of Screening and until at least 90 days after the last dose of investigational product
7. Must provide written informed consent and agree to comply with the study protocol. In participants with hepatic encephalopathy which may impair decision-making, consent will be obtained per hospital procedures (e.g., by Legally Authorized Representative).
8. Participants must agree to participate in an alcohol use disorder program during the study period, as recommended by the local institution's addiction medicine specialists, including post-hospitalization
Exclusion Criteria
2. Participants taking \>2 doses of systemic corticosteroids within 30 days prior to randomization.
3. Participants who have been inpatient at a referral hospital for \>7 days prior to transfer.
4. Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding.
5. Abstinence from alcohol consumption for \>2 months before Day 1.
6. AST or ALT \>400 U/L.
7. Cohort 1 through Cohort 4: mDF \<32 or \>70.
8. Cohort 5 and Cohort 6: mDF \<32
9. Cohort 1 through Cohort 4: MELD score \<18 or \>25.
10. Cohort 5 and Cohort 6: MELD \<21 or \>30
11. Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen \[HBsAg\] positive), chronic hepatitis C virus (HCV) RNA positive, drug-induced liver injury (DILI), biliary obstruction, and autoimmune liver disease.
12. Current or previous history of hepatocellular carcinoma (HCC)
13. History of liver transplantation or currently listed for liver transplant
14. Untreated infection (e.g., has not initiated appropriate medical treatment for infection)
15. Known positivity for human immunodeficiency virus infection
16. Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding that was associated with shock or required transfusion of more than 3 units of blood within 7 days of Screening.
17. Kidney injury defined as a serum creatinine \>133 μmol/L (\>1.5 mg/dL) or the requirement for renal replacement therapy whether prior to or after study screening.
18. Portal vein thrombosis
19. Acute pancreatitis or acute gallbladder disease (e.g., cholecystitis)
20. Severe, on-going associated disease (e.g., cardiac failure, acute myocardial infarction, severe cardiac arrhythmias, severe pulmonary disease, neurologic disease)
21. Malignancy within the 2 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection (e.g., basal cell skin cancer). Participants under evaluation for possible malignancy are not eligible.
22. Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cocaine, and opiates) except tetrahydrocannabinol or in the setting of documented prescription medications (e.g., opiates, benzodiazepines, amphetamines, barbiturates), which also include medications prescribed as part of in-patient management. Participants being treated for alcohol withdrawal may be exempt for this reason, verify with Medical Monitor.
23. Participated in a clinical research study and received any active investigational product being evaluated for the treatment of sAH within 3 months before Day 1
24. Participation in a study of another investigational medicine or device within 30 days before Screening
25. Any other condition or clinical laboratory result that, in the opinion of the Investigator, might confound the results, or would impede compliance or hinder completion of the study
26. Participants treated in the Dose Escalation Phase (Cohort 1 through Cohort 4) are not eligible for enrollment into an Extension Cohort (Cohort 5 and Cohort 6), and participants treated in Cohort 5 are not eligible for enrollment into Cohort 6.
18 Years
65 Years
ALL
No
Sponsors
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Intercept Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Stanford Healthcare
Palo Alto, California, United States
Clinical Translational Research Site
Miami, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Mercy Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Rutgers-New Jersey Medical School
Newark, New Jersey, United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Digestive Disease Center
Nashville, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
VCU Health Clinical Research Services Unit
Richmond, Virginia, United States
CHU Angers
Angers, France, France
Hopital Beaujon
Clichy, , France
Hopital Claude Huriez
Lille, , France
Hopital Pitie Salpetriere
Paris, , France
Hopital Rangueil
Toulouse, , France
Cambridge University NHS Foundation Trust
Cambridge, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Stanford Healthcare
Role: primary
Clinical Translational Research Site
Role: primary
Tampa General Medical Group
Role: primary
Rush University Medical Center
Role: primary
Mercy Medical Center
Role: primary
Beth Israel Deaconess Medical Center
Role: primary
Henry Ford Health System
Role: primary
Mayo Clinic Hospital
Role: primary
Northwell Health Center for Liver Disease and Transplantation
Role: primary
Columbia University Medical Center/ New York Presbyterian Hospital
Role: primary
Hospital of the University of Pennsylvania
Role: primary
Medical University of South Carolina
Role: primary
Vanderbilt Digestive Disease Center
Role: primary
The Liver Institute at Methodist Dallas Medical Center
Role: primary
Parkland Health Hospital System
Role: primary
University of Texas Southwestern Medical Center
Role: primary
University of Utah Hospital
Role: primary
VCU Health Clinical Research Services Unit
Role: primary
CHU Angers
Role: primary
Hopital Beaujon
Role: primary
Hopital Claude Huriez
Role: primary
Hopital Pitie Salpetriere
Role: primary
Hopital Rangueil
Role: primary
Cambridge University NHS Foundation Trust
Role: primary
Royal Free Hospital
Role: primary
Imperial College Healthcare NHS Trust
Role: primary
University Hospitals Plymouth NHS Trust
Role: primary
Other Identifiers
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787-201
Identifier Type: -
Identifier Source: org_study_id
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