Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Durect

Collaborator: CTI Clinical Trial and Consulting Services

Stanford Investigator(s):

Intervention(s):

  • Drug: DUR-928 30 mg
  • Drug: DUR-928 90 mg
  • Drug: Placebo+ Standard of Care (SOC)

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Thuy Nhi Huynh
(650)497-4070
Recruiting