NCT03917407 (DUR-928/AH) is a Phase 2 clinical trial of DUR-928 (Moderate AH) in Alcoholic Hepatitis, sponsored by Craig James McClain.

Who is sponsoring NCT03917407?

NCT03917407 is sponsored by Craig James McClain.

What drugs are being tested in NCT03917407?

Interventions in NCT03917407: DUR-928 (Moderate AH), DUR-928 (Severe AH).

What condition does NCT03917407 study?

NCT03917407 studies Alcoholic Hepatitis.

Is NCT03917407 still recruiting?

NCT03917407 is currently completed. Last updated 18 October 2023.

Last reviewed 2023-10-18 · How we verify

NCT03917407: DUR-928/AH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

DUR-928 in Patients With Alcoholic Hepatitis

Completed Phase 2 Last updated 18 October 2023

What this trial tests

Phase 2 trial testing DUR-928 (Moderate AH) in Alcoholic Hepatitis in 43 participants. Completed in 30 September 2023.

Timeline

1 June 2021

Primary endpoint
24 September 2023

30 September 2023

Quick facts

Lead sponsor	Craig James McClain
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	1 June 2021
Primary completion	24 September 2023
Estimated completion	30 September 2023
Sites	1 location across United States

Drugs / interventions tested

DUR-928 (Moderate AH) — full drug profile →
DUR-928 (Severe AH) — full drug profile →

Conditions studied

Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →

Sponsor

Craig James McClain — full company profile →

Who can join

Adults 21 to 67, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study is An Open-Label, Dose Escalation Study to Assess the Safety, and Pharmacodynamics (PD) signals of DUR 928 in Patients with AH. DUR-928 will be administered in 100 mL 5% dextrose or 0.9% sodium chloride by slow intravenous infusion over 2 hrs (50mL/h) until entire dose is given at Day 1 and Day 4. If a patient meets the hospital discharge criteria prior to the 2nd dose, the patient will receive only one dose of DUR-928 instead of 2 doses.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Interleukin-22 in alcoholic hepatitis and beyond.
Xiang X, Hwang S, Feng D, Shah VH, et al · · 2020 · cited 25× · PMID 32892258 · DOI 10.1007/s12072-020-10082-6
Alcohol-associated liver disease: Natural history, management and novel targeted therapies.
Alvarado-Tapias E, Pose E, Gratacós-Ginès J, Clemente-Sánchez A, et al · · 2025 · cited 21× · PMID 39481875 · DOI 10.3350/cmh.2024.0709
Emerging medical therapies for severe alcoholic hepatitis.
Tornai D, Szabo G. · · 2020 · cited 19× · PMID 32981291 · DOI 10.3350/cmh.2020.0145
Targeting Liver X Receptors for the Treatment of Non-Alcoholic Fatty Liver Disease.
Kim H, Park C, Kim TH. · · 2023 · cited 17× · PMID 37174692 · DOI 10.3390/cells12091292
Alcohol-related hepatitis: A review article.
Chaudhry H, Sohal A, Iqbal H, Roytman M. · · 2023 · cited 12× · PMID 37213401 · DOI 10.3748/wjg.v29.i17.2551
Current Management and Future Treatment of Alcoholic Hepatitis.
Mitchell MC, Kerr T, Herlong HF. · · 2020 · cited 12× · PMID 34035720
Therapeutic Pipeline in Alcohol-Associated Liver Disease.
Thakral N, Deutsch-Link S, Singal AK. · · 2023 · cited 8× · PMID 36572032 · DOI 10.1055/s-0042-1759614
Therapeutic targets in alcohol-associated liver disease: progress and challenges.
Adekunle AD, Adejumo A, Singal AK. · · 2023 · cited 6× · PMID 37187673 · DOI 10.1177/17562848231170946

Verify or expand the search:

Other recruiting trials for Alcoholic Hepatitis

Currently open trials in the same condition.

NCT06919458 — Short Course Steroids in Alcohol Associated Hepatitis · Phase 3 · recruiting
NCT06307964 — Intra-Hepatic Microbiota in Alcoholic Hepatitis · recruiting
NCT05006430 — Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis · Phase 1, PHASE2 · recruiting
NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study · EARLY_PHASE1 · recruiting
NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03917407 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Craig James McClain
Last refreshed: 18 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03917407.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing