RECRUITING

FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study

Conditions

Alcohol Associated Hepatitis Severe Alcohol associated Hepatitis (sAH)Alcoholic Hepatitis (AH)Hepatitis Alcoholic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).

Official Title

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects With Severe Alcohol Associated Hepatitis

Quick Facts

Study Start:2022-12-15

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05639543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males or females aged 18 to 65 years (inclusive) 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. Maddrey's Discriminant Factor (mDF) ≥32 and ≤70 3. MELD score 18 to 25 (inclusive) 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: 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 5. Male participants who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use 1 other approved method of highly effective contraception from the initiation of Screening and until at least 90 days after the dose of investigational product as listed in Inclusion Criteria #3. 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	1. Participants taking products containing obeticholic acid in the 30 days prior to randomization 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. mDF \<32 or \>70 at Screening 8. MELD score \<18 or \>25 at Screening. 9. 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. 10. Current or previous history of hepatocellular carcinoma (HCC) 11. History of liver transplantation or currently listed for liver transplant 12. Untreated infection (e.g., has not initiated appropriate medical treatment for infection) 13. Known positivity for human immunodeficiency virus infection 14. 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. 15. Kidney injury defined as a serum creatinine \>133 μmol/L (\>1.5 mg/dL) or the requirement for renal replacement therapy. 16. Portal vein thrombosis 17. Acute pancreatitis or acute gallbladder disease (e.g., cholecystitis) 18. Severe, on-going associated disease (e.g., cardiac failure, acute myocardial infarction, severe cardiac arrhythmias, severe pulmonary disease, neurologic disease) 19. 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. 20. 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. 21. 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 22. Participation in a study of another investigational medicine or device within 30 days before Screening 23. 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

Inclusion Criteria

Exclusion Criteria

1. Males or females aged 18 to 65 years (inclusive)
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. Maddrey's Discriminant Factor (mDF) ≥32 and ≤70
3. MELD score 18 to 25 (inclusive)
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: 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
5. Male participants who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use 1 other approved method of highly effective contraception from the initiation of Screening and until at least 90 days after the dose of investigational product as listed in Inclusion Criteria #3.
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

1. Participants taking products containing obeticholic acid in the 30 days prior to randomization
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. mDF \<32 or \>70 at Screening
8. MELD score \<18 or \>25 at Screening.
9. 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.
10. Current or previous history of hepatocellular carcinoma (HCC)
11. History of liver transplantation or currently listed for liver transplant
12. Untreated infection (e.g., has not initiated appropriate medical treatment for infection)
13. Known positivity for human immunodeficiency virus infection
14. 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.
15. Kidney injury defined as a serum creatinine \>133 μmol/L (\>1.5 mg/dL) or the requirement for renal replacement therapy.
16. Portal vein thrombosis
17. Acute pancreatitis or acute gallbladder disease (e.g., cholecystitis)
18. Severe, on-going associated disease (e.g., cardiac failure, acute myocardial infarction, severe cardiac arrhythmias, severe pulmonary disease, neurologic disease)
19. 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.
20. 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.
21. 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
22. Participation in a study of another investigational medicine or device within 30 days before Screening
23. 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

Contacts and Locations

Study Contact

Steven Lauder

CONTACT

858-652-6800

steven.lauder@interceptpharma.com

Thomas Capozza

CONTACT

646-747-1000

thomas.capozza@interceptpharma.com

Study Locations (Sites)

Clinical Translational Research Site

Miami, Florida, 33136

United States

Tampa General Medical Group

Tampa, Florida, 33606

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Mercy Medical Center

Baltimore, Maryland, 21202

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

UMass Memorial Medical Center

Worcester, Massachusetts, 01655

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Rutgers-New Jersey Medical School

Newark, New Jersey, 07103

United States

Northwell Health Center for Liver Disease and Transplantation

Manhasset, New York, 11030

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Vanderbilt Digestive Disease Center

Nashville, Tennessee, 37232

United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203

United States

Parkland Health and Hospital System

Dallas, Texas, 75235

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

VCU Health Clinical Research Services Unit

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Intercept Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-15

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-12-15

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

Severe Alcohol associated Hepatitis (sAH)
Alcoholic Hepatitis (AH)
Hepatitis
Alcoholic

Additional Relevant MeSH Terms

Alcohol Associated Hepatitis