A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

Not Recruiting

Trial ID: NCT04563026


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).

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis

Stanford Investigator(s)

Aparna Goel

Clinical Associate Professor, Medicine - Gastroenterology & Hepatology


Inclusion Criteria:

   1. Able to provide written informed consent (either from subject or subject's legally
   acceptable representative).

   2. Onset of jaundice within prior 8 weeks.

   3. 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.

   4. The determination of AH may be based on typical serum chemistry (as determined by
   local laboratory) or liver biopsy at any time during the current episode of AH:

      - Serum total bilirubin > 3.0 mg/dL

      - 50 < AST < 400 IU/L

      - ALT < 400 IU/L

      - AST/ALT > 1.5

   5. Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12

   6. Model for End-stage Liver Disease (MELD) score: 21-30.

   7. Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the
   Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have
   occurred during the current episode.

   8. Male or female subjects 18 years of age or older.

   9. Subjects must agree to use effective methods to prevent pregnancy while participating
   in the study.

10. Subjects must agree to participate in an alcohol abstinence support program
   recommended by the local institution's addiction specialists.

Exclusion Criteria:

   1. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30
   days prior to screening.

   2. Subjects experiencing or considered at high risk for alcohol withdrawal seizures or
   delirium tremens.

   3. Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract
   infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS
   CoV2 infection).

   4. Serum creatinine >2.5 mg/dL.

   5. Subjects undergoing continuous veno-venous hemodialysis (CVVH).

   6. Uncontrolled gastrointestinal bleeding.

   7. A history of pre-admission refractory ascites defined as more than 4 paracenteses in
   the previous 8 weeks despite diuretic therapy.

   8. Liver biopsy (if carried out) with findings not compatible with AH.

   9. Stage ≥3 hepatic encephalopathy by West Haven criteria.

10. Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric
   disorder, or multi-organ failure.

11. Other concomitant cause(s) of liver disease.

12. Any active malignancy or any malignancy diagnosed within the last five years other
   than curable skin cancer (basal cell or squamous cell carcinomas).

13. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and
   opiates) except THC and prescription medications.

14. Existing or intended pregnancy or breast feeding.

15. Participation in another interventional clinical trial within 30 days of Screening.

16. History of organ transplantation, other than a corneal transplant.

17. 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.


drug: DUR-928 30 mg

drug: DUR-928 90 mg

drug: Placebo+ Standard of Care (SOC)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Thuy Nhi Huynh