Phase II
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
- Study HIC#:2000030511
- Last Updated:04/21/2023
This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Ricarda Tomlin
- Phone Number: 1-203-785-2073
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Trial Purpose and Description
This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
Eligibility Criteria
Inclusion Criteria:
- Able to provide written informed consent (either from subject or subject's legally acceptable representative)
- Onset of jaundice within prior 8 weeks
- Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made by the site investigator.
- Serum chemistry (as determined by local laboratory):
- Serum total bilirubin > 3.0 mg/dL
- 50 < AST < 400 IU/L
- ALT < 400 IU/L
- AST/ALT > 1.5
- Maddrey's discriminant function ≥ 32 assuming a control prothrombin time of 12 seconds
- Model for End-stage Liver Disease (MELD) score: 21-30
- When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required. Historical biopsy is allowed.
- Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
- Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists
Exclusion Criteria:
- Subjects taking corticosteroids for a duration exceeding 7 days in the 30 days prior to screening
- Subjects experiencing alcohol withdrawal symptoms or treatment with Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol
- Active infection. Subjects who are febrile with leukocytosis are also excluded, even if there is no localizing diagnosis of infection.
- Serum creatinine >2.5 mg/dL or eGFR < 60 mL/min/1.73 m2
- Subjects with acute kidney injury (AKl) or Hepatorenal syndrome
- Subjects undergoing continuous veno-venous hemodialysis (CVVH)
- Uncontrolled active gastrointestinal bleeding
- Refractory ascites
- Liver biopsy (if carried out) with findings not compatible with AH
- Stage ≥3 hepatic encephalopathy by West Haven criteria
- Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure
- Other concomitant cause(s) of liver disease
- Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years
- Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications
- Existing or intended pregnancy or breast feeding
- Participation in another interventional clinical trial within 30 days of Screening
- History of organ transplantation, other than a corneal transplant
- Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.