Print Send My Information

Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
INT-787 		Participants will be randomized to receive INT-787 (escalating doses through the cohorts)
  • Drug: INT-787
    Blinded Study Drug
Placebo Comparator
Placebo 		Participants will be randomized to receive matching placebo
  • Drug: Placebo
    Placebo

Recruiting Locations

Clinical Translational Research Site
Miami, Florida 33136
Contact:
Clinical Translational Research Site

Tampa General Medical Group
Tampa, Florida 33606
Contact:
Tampa General Medical Group

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Rush University Medical Center

Mercy Medical Center
Baltimore, Maryland 21202
Contact:
Mercy Medical Center

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Beth Israel Deaconess Medical Center

Henry Ford Health System
Detroit, Michigan 48202
Contact:
Henry Ford Health System

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Mayo Clinic Hospital

Rutgers-New Jersey Medical School
Newark, New Jersey 07103
Contact:
Rutgers New Jersey Medical School

Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York 11030
Contact:
Northwell Health Center for Liver Disease and Transplantation

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Hospital of the University of Pennsylvania

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Medical University of South Carolina

Vanderbilt Digestive Disease Center
Nashville, Tennessee 37232
Contact:
Vanderbilt Digestive Disease Center

The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas 75203
Contact:
The Liver Institute at Methodist Dallas Medical Center

Parkland Health and Hospital System
Dallas, Texas 75235
Contact:
Parkland Health Hospital System

University of Texas Southwestern Medical Center
Dallas, Texas 75390
Contact:
University of Texas Southwestern Medical Center

VCU Health Clinical Research Services Unit
Richmond, Virginia 23298
Contact:
VCU Health Clinical Research Services Unit

More Details

NCT ID
NCT05639543
Status
Recruiting
Sponsor
Intercept Pharmaceuticals

Study Contact

Steven Lauder
858-652-6800
steven.lauder@interceptpharma.com

Detailed Description

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, proof-of-concept study to evaluate the safety, tolerability, efficacy, and PK of INT-787 in participants, initially admitted to the hospital, with severe alcohol-associated hepatitis (sAH). The study aims to demonstrate and provide rationale for the selection of optimal dose(s) of INT-787 in the target population of participants with sAH. INT-787 will be evaluated for safety and tolerability prior to dose escalation. Overall efficacy, compared to placebo, will be assessed for each dose cohort. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center