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

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ClinicalTrials.gov Identifier: NCT04563026
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Durect

Tracking Information
First Submitted Date  ICMJE September 18, 2020
First Posted Date  ICMJE September 24, 2020
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE January 22, 2021
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
90-day mortality between active group/s and placebo (SOC) group [ Time Frame: Day 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Alcoholic Hepatitis
Intervention  ICMJE
  • Drug: DUR-928 30 mg
    IV infusion
  • Drug: DUR-928 90 mg
    IV infusion
  • Drug: Placebo+ Standard of Care (SOC)
    IV infusion
Study Arms  ICMJE
  • Experimental: DUR-928 (30 mg)
    Intervention: Drug: DUR-928 30 mg
  • Experimental: DUR-928 (90 mg)
    Intervention: Drug: DUR-928 90 mg
  • Placebo Comparator: (Placebo) Sterile Water for Injection
    Intervention: Drug: Placebo+ Standard of Care (SOC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christina Blevins, BS 408-777-1417 christina.blevins@durect.com
Contact: Deborah Scott, MS 408-777-1417 deborah.scott@durect.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04563026
Other Study ID Numbers  ICMJE C928-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Durect
Study Sponsor  ICMJE Durect
Collaborators  ICMJE CTI Clinical Trial and Consulting Services
Investigators  ICMJE
Study Director: Robert Gordon, MD, FACS CTI Clinical Trial and Consulting Services
PRS Account Durect
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP