A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04563026 |
Recruitment Status :
Recruiting
First Posted : September 24, 2020
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholic Hepatitis | Drug: DUR-928 30 mg Drug: DUR-928 90 mg Drug: Placebo+ Standard of Care (SOC) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a Phase 2b randomized, double-blind, placebo-controlled, multi-arm, multi-center, parallel design trial. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis |
Actual Study Start Date : | January 22, 2021 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | September 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: DUR-928 (30 mg) |
Drug: DUR-928 30 mg
IV infusion |
Experimental: DUR-928 (90 mg) |
Drug: DUR-928 90 mg
IV infusion |
Placebo Comparator: (Placebo) Sterile Water for Injection |
Drug: Placebo+ Standard of Care (SOC)
IV infusion |
- 90-day mortality between active group/s and placebo (SOC) group [ Time Frame: Day 90 ]
- 28-day mortality between the treatment groups [ Time Frame: Day 28 ]
- Occurrence of adverse events or laboratory abnormalities [ Time Frame: Day 1 to Day 90 ]Percentage of Participants with Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Laboratory Abnormalities within 90 days of dosing
- Lille score at Day 7 after the initiation of study drug treatment between the treatment groups [ Time Frame: Day 7 ]
- MELD score at Day 28 after the initiation of study drug treatment between the treatment groups [ Time Frame: Day 28 ]
- ICU days at Day 28 [ Time Frame: Day 1 to Day 28 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563026
Contact: Christina Blevins, BS | 408-777-1417 | christina.blevins@durect.com | |
Contact: Deborah Scott, MS | 408-777-1417 | deborah.scott@durect.com |
United States, California | |
Site 01 | Not yet recruiting |
Coronado, California, United States, 92118 | |
United States, Georgia | |
Site 02 | Recruiting |
Atlanta, Georgia, United States, 30309 | |
United States, Illinois | |
Site 09 | Not yet recruiting |
Chicago, Illinois, United States, 60611 | |
Site 03 | Recruiting |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Site 07 | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Site 10 | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Site 06 | Recruiting |
Detroit, Michigan, United States, 48202 | |
United States, New Jersey | |
Site 04 | Recruiting |
Newark, New Jersey, United States, 07103 | |
United States, New York | |
Site 08 | Recruiting |
Manhasset, New York, United States, 11030 | |
United States, Texas | |
Site 11 | Not yet recruiting |
Dallas, Texas, United States, 75203 | |
United States, Virginia | |
Site 05 | Recruiting |
Richmond, Virginia, United States, 23226 |
Study Director: | Robert Gordon, MD, FACS | CTI Clinical Trial and Consulting Services |
Responsible Party: | Durect |
ClinicalTrials.gov Identifier: | NCT04563026 |
Other Study ID Numbers: |
C928-011 |
First Posted: | September 24, 2020 Key Record Dates |
Last Update Posted: | February 2, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alcoholic Hepatitis acute alcoholic liver disease progressive inflammatory liver injury |
Hepatitis A Hepatitis Hepatitis, Alcoholic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Liver Diseases, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |