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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durect
• Collaborator: CTI Clinical Trial and Consulting Services

Criteria

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. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made by the site investigator.

4. 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

5. Maddrey's discriminant function ≥ 32 assuming a control prothrombin time of 12 seconds

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

7. 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.

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

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

Exclusion Criteria:

1. Subjects taking corticosteroids for a duration exceeding 7 days in the 30 days prior to screening

2. Subjects experiencing alcohol withdrawal symptoms or treatment with Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol

3. Active infection. Subjects who are febrile with leukocytosis are also excluded, even if there is no localizing diagnosis of infection.

4. Serum creatinine >2.5 mg/dL or eGFR < 60 mL/min/1.73 m2

5. Subjects with acute kidney injury (AKl) or Hepatorenal syndrome

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

7. Uncontrolled active gastrointestinal bleeding

8. Refractory ascites

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

10. Stage ≥3 hepatic encephalopathy by West Haven criteria

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

12. Other concomitant cause(s) of liver disease

13. 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

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

15. Existing or intended pregnancy or breast feeding

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

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

18. 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