A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
a study on Alcoholic Hepatitis Hepatitis A Hepatitis
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
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).
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
Keywords
Alcoholic Hepatitis, acute alcoholic liver disease, progressive inflammatory liver injury, Hepatitis A, Hepatitis, DUR-928 30 mg, DUR-928 90 mg, DUR-928 (larsucosterol, 30 mg), DUR-928 (larsucosterol, 90 mg)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
- 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
- Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
- Model for End-stage Liver Disease (MELD) score: 21-30.
- 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.
- Male or female subjects 18 years of age or older.
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.
You CAN'T join if...
- Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
- Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
- Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
- Serum creatinine >2.5 mg/dL.
- Subjects undergoing continuous veno-venous hemodialysis (CVVH).
- Uncontrolled gastrointestinal bleeding.
- A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
- Liver biopsy (if carried out) with findings not compatible with AH.
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.
Locations
- UCSF (UCSF) Medical Center
accepting new patients
San Francisco California 94143 United States - Stanford University Medical Center
accepting new patients
Stanford California 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Durect
- ID
- NCT04563026
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 300 study participants
- Last Updated
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT04563026.