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FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
EU CTIS ID: 2024-512913-42-00
What this study is testing
To evaluate the efficacy of INT-787 as assessed by disease progression in severe alcohol-associated hepatitis (sAH)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females aged 18 to 65 years (inclusive)
- Clinical diagnosis of sAH based on all the following: a. 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 b. Serum total bilirubin >3.0 mg/dL c. AST ≥50 U/L d. AST/ALT ratio ≥1.5 e. Onset of jaundice within prior 8 weeks f. Cohort 1 through Cohort 4: mDF ≥32 and ≤70 g. Cohort 5 and Cohort 6: mDF ≥32 h. Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 i. Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
- Female patients 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 hormonereleasing 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.
- Male patients 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
- Male patients must refrain from sperm donation from the initiation of Screening and until at least 90 days after the last dose of investigational product.
- Must provide written informed consent and agree to comply with the study protocol. In patients with hepatic encephalopathy which may impair decision-making, consent will be obtained per hospital procedures (e.g., by Legally Authorized Representative).
You likely can't join if
- 1. Patients taking products containing obeticholic acid in the 30 days prior to randomization
- 20. Severe, ongoing 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). Patients under evaluation for possible malignancy are not eligible
- 2. Patients taking >2 doses of systemic corticosteroids within 30 days prior to randomization
- 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 inpatient management. Patients 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
See the full eligibility criteria
Who can join
- Males or females aged 18 to 65 years (inclusive)
- Clinical diagnosis of sAH based on all the following: a. 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 b. Serum total bilirubin >3.0 mg/dL c. AST ≥50 U/L d. AST/ALT ratio ≥1.5 e. Onset of jaundice within prior 8 weeks f. Cohort 1 through Cohort 4: mDF ≥32 and ≤70 g. Cohort 5 and Cohort 6: mDF ≥32 h. Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 i. Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
- Female patients 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 hormonereleasing 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.
- Male patients 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
- Male patients must refrain from sperm donation from the initiation of Screening and until at least 90 days after the last dose of investigational product.
- Must provide written informed consent and agree to comply with the study protocol. In patients with hepatic encephalopathy which may impair decision-making, consent will be obtained per hospital procedures (e.g., by Legally Authorized Representative).
- Patients 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.
What rules you out
- 1. Patients taking products containing obeticholic acid in the 30 days prior to randomization
- 20. Severe, ongoing 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). Patients under evaluation for possible malignancy are not eligible
- 2. Patients taking >2 doses of systemic corticosteroids within 30 days prior to randomization
- 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 inpatient management. Patients 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
- 3. Patients 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 breastfeeding
- 5. Abstinence from alcohol consumption for >2 months before Day 1
- 12. Current or previous history of hepatocellular carcinoma (HCC)
- 6. AST or ALT >400 U/L
- 7. Cohort 1 through Cohort 4: mDF <32 or >70
- 9. Cohort 1 through Cohort 4: MELD score <18 or >25
- 11. Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HbsAg] positive), chronic hepatitis C virus (HCV) RNA positive, DILI, biliary obstruction, and autoimmune liver disease
- 8. Cohort 5 and Cohort 6: mDF <32
- 10. Cohort 5 and Cohort 6: MELD <21 or >30
- 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
- 13. History of liver transplantation or currently listed for liver transplantation
- 14. Uncontrolled 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
- 18. Portal vein thrombosis
- 19. Acute pancreatitis or acute gallbladder disease (e.g., cholecystitis)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.