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

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 : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Durect

Brief 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).

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

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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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 90-day mortality between active group/s and placebo (SOC) group [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. 28-day mortality between the treatment groups [ Time Frame: Day 28 ]
  2. 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

  3. Lille score at Day 7 after the initiation of study drug treatment between the treatment groups [ Time Frame: Day 7 ]
  4. MELD score at Day 28 after the initiation of study drug treatment between the treatment groups [ Time Frame: Day 28 ]
  5. ICU days at Day 28 [ Time Frame: Day 1 to Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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


Contacts
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Contact: Christina Blevins, BS 408-777-1417 christina.blevins@durect.com
Contact: Deborah Scott, MS 408-777-1417 deborah.scott@durect.com

Locations
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United States, California
Site 01
Coronado, California, United States, 92118
United States, Georgia
Site 02
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Durect
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Robert Gordon, MD, FACS CTI Clinical Trial and Consulting Services
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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT04563026    
Other Study ID Numbers: C928-011
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Durect:
Alcoholic Hepatitis
acute alcoholic liver disease
progressive inflammatory liver injury
Additional relevant MeSH terms:
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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