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 |
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Recruitment Status :
Recruiting
First Posted : September 24, 2020
Last Update Posted : August 10, 2022
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Sponsor:
Durect
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Durect
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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 |
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: DUR-928 (larsucosterol, 30 mg) |
Drug: DUR-928 30 mg
IV infusion |
| Experimental: DUR-928 (larsucosterol, 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 :
- Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo. [ Time Frame: Day 90 ]
Secondary Outcome Measures :
- Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo. [ Time Frame: Day 90 ]
- Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo. [ Time Frame: Day 28 ]
- Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo. [ Time Frame: Day 28 ]
Information from the National Library of Medicine
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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:
- 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.
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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.
- Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
Exclusion Criteria:
- 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.
- Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
- Other concomitant cause(s) of liver disease.
- Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
- 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.
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
| Contact: Christina Blevins, BS | 408-777-1417 | christina.blevins@durect.com | |
| Contact: Deborah Scott, MS | 408-777-1417 | deborah.scott@durect.com |
Locations
Show 66 study locations
Sponsors and Collaborators
Durect
CTI Clinical Trial and Consulting Services
Investigators
| 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: | August 10, 2022 |
| Last Verified: | August 2022 |
| 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 |
Keywords provided by Durect:
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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 Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Liver Diseases, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |