Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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 ?mol/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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/22/2024. Questions regarding updates should be directed to the study team contact.