Alcoholic HepatitisPhase 2AHNCT03432260

A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

A Phase 2 study testing DUR-928 30 mg, DUR-928 90 mg and DUR-928 150 mg in people with Alcoholic Hepatitis, run by Durect at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH). Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Alcoholic Hepatitis
What is being tested?: DUR-928 30 mg, DUR-928 90 mg and DUR-928 150 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 7 sitesUnited States
Study dates: 18 Apr 2018to 9 Sep 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to provide written informed consent (either from patient or patient's legally acceptable representative)
Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
Patients with alcoholic hepatitis defined as:
History of heavy alcohol abuse: > 40 g/day in females or > 60 g/day in males for a minimum period of 6 months, AND
Consumed alcohol within 12 weeks of entry into the study, AND
Serum bilirubin > 3 mg/dL AND AST > ALT, but less than 300 U/L AND

Show all 10Show fewer

MELD score between 11-30, inclusive
No evidence of active infection as determined by the investigator.
Women of child-bearing potential must utilize appropriate birth control throughout the study duration.
Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration

Who cannot join

Other or concomitant cause(s) of liver disease as a result of:
Autoimmune liver disease
Wilson disease
Vascular liver disease
Drug induced liver disease
Co-infection with human immunodeficiency virus (HIV) or Hepatitis B

Show all 11Show fewer

Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
Serum creatinine > 2.5 mg/dL
Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
Stage 3 or greater encephalopathy by West Haven criteria

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

DURECT Study Site 0004
Atlanta, Georgia, 30309
DURECT Study Site 0002
Chicago, Illinois, 60611
DURECT Study Site 008
Indianapolis, Indiana, 46202
DURECT Study Site 0005
Louisville, Kentucky, 40202
DURECT Study Site 007
Miami, Florida, 33136
DURECT Study Site 006
San Antonio, Texas, 78215
DURECT Study Site 0001
San Diego, California, 92118

Other trials in United States

About this study

Official title: An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis

Conditions: Alcoholic Hepatitis
Being tested: DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
Keywords: Alcoholic Hepatitis, acute alcoholic liver disease, progressive inflammatory liver injury, IV infusion
Medical subject headings: Hepatitis, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DUR-928 30 mgDrug
Lowest dose of 3 dose escalation arms.
DUR-928 90 mgDrug
Middle dose of 3 dose escalation arms.
DUR-928 150 mgDrug
Highest dose of 3 dose escalation arms.

Study groups in NCT03432260
Study group	Role	What they receive
Part A (Moderate AH) DUR-928 30 mg	Experimental	Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg Receives: Drug: DUR-928 30 mg
Part A (Moderate AH) DUR-928 90 mg	Experimental	Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg Receives: Drug: DUR-928 90 mg
Part A (Moderate AH) DUR-928 150 mg	Experimental	Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg Receives: Drug: DUR-928 150 mg
Part B (Severe AH) DUR-928 30 mg	Experimental	Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg Receives: Drug: DUR-928 30 mg
Part B (Severe AH) DUR-928 90 mg	Experimental	Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg Receives: Drug: DUR-928 90 mg
Part B (Severe AH) DUR-928 150 mg	Experimental	Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg Receives: Drug: DUR-928 150 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Lille Model for Alcoholic Hepatitis Score
The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score >0.45 predicts a higher risk of death and the recommendation to stop steroid administration.
Lille Score = Exp(-R)/(1 + Exp(-R))
Where:
R = [3.19 - (0.101 x Age in years)] + (1.47 x Albumin in g/dL) + [0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result.
Measured: Day 7
Model for End Stage Liver Disease (MELD) Score
The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery.
MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level.
Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.
Measured: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28
Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline
The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.
Measured: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28

Secondary outcomes (4)

Serum Cytokeratin 18 (M30)
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
Measured: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
Serum Cytokeratin 18 (M65)
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
Measured: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
International Normalized Ratio (INR) - Percent Change From Baseline
ITT population. INR (international normalized ratio) is a standardized number based on the prothrombin time and calculated by the clinical lab. INR measures the time it takes for blood to clot in vitro and measures, among other things, liver synthetic function.
Measured: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
Bilirubin - Percent Change From Baseline
ITT population
Measured: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 20189 Sep 2019

First posted14 Feb 2018
Study start18 Apr 2018
Primary completion9 Sep 2019
Study completion9 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Staggered parallel design.
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03432260
Sponsor's protocol ID: C928-010
Acronym: AH
Status last verified: Nov 2022
First submitted: 1 Feb 2018
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Hassanein T, McClain CJ, Vatsalya V, Stein LL, Flamm SL, Martin P, Cave MC, Mitchell M Jr, Barton B, Nagy L, Szabo G, McCullough A, Dasarathy S, Shah J, Blevins C, Scott D, Krebs W, Brown JE, Lin W. Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis. Am J Gastroenterol. 2024 Jan 1;119(1):107-115. doi: 10.14309/ajg.0000000000002275. Epub 2023 Apr 3.
PubMed 37011138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Hepatitis
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C

All Alcoholic Hepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis
ClinicalTrials.gov ID: NCT03432260
Acronym / sponsor ID: AH / C928-010
Conditions: Alcoholic Hepatitis
Keywords: Alcoholic Hepatitis, acute alcoholic liver disease, progressive inflammatory liver injury, IV infusion
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: DurectIndustry (pharma, biotech, devices)
Collaborators: CTI Clinical Trial and Consulting Services
Study start: 18 Apr 2018 (actual)
Primary completion: 9 Sep 2019 (actual)
Study completion: 9 Sep 2019 (actual)
First posted: 14 Feb 2018 (actual)
Results: Posted 14 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: Staggered parallel design.

Arm	Type	Receives
Part A (Moderate AH) DUR-928 30 mg	Experimental	Drug: DUR-928 30 mgLowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg
Part A (Moderate AH) DUR-928 90 mg	Experimental	Drug: DUR-928 90 mgMiddle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg
Part A (Moderate AH) DUR-928 150 mg	Experimental	Drug: DUR-928 150 mgHighest dose of dose escalation arms: 30mg, 90 mg and 150 mg
Part B (Severe AH) DUR-928 30 mg	Experimental	Drug: DUR-928 30 mgLowest dose of dose escalation arms: 30mg, 90 mg and 150 mg
Part B (Severe AH) DUR-928 90 mg	Experimental	Drug: DUR-928 90 mgMiddle dose of dose escalation arms: 30mg, 90 mg and 150 mg
Part B (Severe AH) DUR-928 150 mg	Experimental	Drug: DUR-928 150 mgHighest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Able to provide written informed consent (either from patient or patient's legally acceptable representative)
Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
Patients with alcoholic hepatitis defined as:
No evidence of active infection as determined by the investigator.
Women of child-bearing potential must utilize appropriate birth control throughout the study duration.

Key exclusion criteria (11 listed)

Other or concomitant cause(s) of liver disease as a result of:
Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
Serum creatinine > 2.5 mg/dL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DUR-928 30 mgLowest dose of 3 dose escalation arms.	Drug	Part A (Moderate AH) DUR-928 30 mg, Part B (Severe AH) DUR-928 30 mg
DUR-928 90 mgMiddle dose of 3 dose escalation arms.	Drug	Part A (Moderate AH) DUR-928 90 mg, Part B (Severe AH) DUR-928 90 mg
DUR-928 150 mgHighest dose of 3 dose escalation arms.	Drug	Part A (Moderate AH) DUR-928 150 mg, Part B (Severe AH) DUR-928 150 mg

Primary outcome

Lille Model for Alcoholic Hepatitis Score
Time frame: Day 7
The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score >0.45 predicts a higher risk of death and the recommendation to stop steroid administration. Lille Score = Exp(-R)/(1 + Exp(-R)) Where: R = [3.19 - (0.101 x Age in years)] + (1.47 x Albumin in g/dL) + [0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result.
Model for End Stage Liver Disease (MELD) Score
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28
The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.
Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28
The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.

4 secondary outcomes

Serum Cytokeratin 18 (M30)
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
Serum Cytokeratin 18 (M65)
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
International Normalized Ratio (INR) - Percent Change From Baseline
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
Bilirubin - Percent Change From Baseline
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28

Results and safety

Results posted to the registry on 14 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate AH DUR-928 30 mg	4	3
Moderate AH DUR-928 90 mg	3	2
Severe AH DUR-928 30 mg	4	4
Severe AH DUR-928 90 mg	4	4
Severe AH DUR-928 150 mg	4	3

Primary outcome: Lille Model for Alcoholic Hepatitis Score

Time frame: Day 7. Median (Full Range). Unit: score on a scale

Measure	Moderate AH DUR-928 30 mg n = 3	Moderate AH DUR-928 90 mg n = 3	Severe AH DUR-928 30 mg n = 4	Severe AH DUR-928 90 mg n = 4	Severe AH DUR-928 150 mg n = 4
Value	0.020 (0.01 to 0.04)	0.050 (0.01 to 0.05)	0.155 (0.05 to 0.19)	0.195 (0.04 to 0.24)	0.420 (0.08 to 0.87)

Population analysed: ITT

Primary outcome: Model for End Stage Liver Disease (MELD) Score

Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28. Median (Full Range). Unit: score on a scale

Measure	Moderate AH DUR-928 30 mg n = 4	Moderate AH DUR-928 90 mg n = 3	Severe AH DUR-928 30 mg n = 4	Severe AH DUR-928 90 mg n = 4	Severe AH DUR-928 150 mg n = 4
Screening	19.5 (15 to 20)	19.0 (14 to 21)	24.5 (21 to 28)	24.5 (21 to 28)	25.0 (23 to 27)
Day 1 Pre-dose	–	20.0 (20 to 20)	23.0 (21 to 26)	24.0 (24 to 24)	23.0 (21 to 26)
Day 7	17.0 (16 to 19)	17.0 (11 to 19)	23.5 (21 to 29)	24.0 (21 to 29)	24.0 (21 to 28)
Day 28	15.0 (12 to 20)	11.5 (8 to 15)	19.0 (16 to 24)	23.5 (17 to 28)	23.0 (19 to 29)

Population analysed: ITT, baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose

Primary outcome: Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline

Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28. Median (Full Range). Unit: Percent Change

Measure	Moderate AH DUR-928 30 mg n = 3	Moderate AH DUR-928 90 mg n = 3	Severe AH DUR-928 30 mg n = 4	Severe AH DUR-928 90 mg n = 4	Severe AH DUR-928 150 mg n = 4
Day 7	-5.00 (-10.5 to 6.7)	-10.53 (-21.4 to -5.0)	0.00 (-8.7 to 3.6)	0.00 (-4.0 to 3.6)	0.00 (-4.3 to 3.7)
Day 28	-20.00 (-21.1 to 0.00)	-33.93 (-42.9 to -25.0)	-26.76 (-35.7 to 14.3)	-8.00 (-19.0 to 8.3)	0.00 (-29.6 to 11.5)

Population analysed: ITT

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate AH DUR-928 30 mg	2 of 4 (50%)	4 of 4 (100%)	0 of 4
Moderate AH DUR-928 90 mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Severe AH DUR-928 30 mg	2 of 4 (50%)	3 of 4 (75%)	0 of 4
Severe AH DUR-928 90 mg	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Severe AH DUR-928 150 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37011138Hassanein T, McClain CJ, Vatsalya V, Stein LL, Flamm SL, Martin P, Cave MC, Mitchell M Jr, Barton B, Nagy L, Szabo G, McCullough A, Dasarathy S, Shah J, Blevins C, Scott D, Krebs W, Brown JE, Lin W. Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis. Am J Gastroenterol. 2024 Jan 1;119(1):107-115. doi: 10.14309/ajg.0000000000002275. Epub 2023 Apr 3.

Related trials for Alcoholic Hepatitis

Active, not recruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Gordon, MD study director

CTI Clinical Trial and Consulting Services

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DUR-928 30 mg, DUR-928 90 mg and DUR-928 150 mg in people with Alcoholic Hepatitis, run by Durect at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lille Model for Alcoholic Hepatitis Score (time frame: Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03432260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.