Trial · NCT03432260
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
NCT03432260, Phase 2, Completed, Durect; results first posted 2022-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis. Trials, record NCT03432260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03432260
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
- NCT number
- NCT03432260
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Durect
- Conditions
- Alcoholic Hepatitis
- Interventions
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- First posted
- 2018-02-14
- Last updated
- 2024-09-24
- Results first posted
- 2022-12-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lille Model for Alcoholic Hepatitis Score | 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. |
| Primary | Model for End Stage Liver Disease (MELD) Score | 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. |
| Primary | Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline | 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. |
| Secondary | Serum Cytokeratin 18 (M30) | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. |
| Secondary | Serum Cytokeratin 18 (M65) | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. |
| Secondary | International Normalized Ratio (INR) - Percent Change From Baseline | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | 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. |
| Secondary | Bilirubin - Percent Change From Baseline | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | ITT population |
| Other | Serum Creatinine (sCR) | Baseline (Screening or Day 1 Pre-dose) | Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lille Model for Alcoholic Hepatitis Score | Day 7 | ITT | score on a scale | MEDIAN |
| PRIMARY | Model for End Stage Liver Disease (MELD) Score | Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28 | ITT, baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose | score on a scale | MEDIAN |
| PRIMARY | Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline | Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28 | ITT | Percent Change | MEDIAN |
| SECONDARY | Serum Cytokeratin 18 (M30) | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | Number analyzed is dependent on samples being collected and evaluable. | U/L | MEDIAN |
| SECONDARY | Serum Cytokeratin 18 (M65) | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | Number analyzed is dependent on samples being collected and evaluable. | U/L | MEDIAN |
| SECONDARY | International Normalized Ratio (INR) - Percent Change From Baseline | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose | Percent Change | MEDIAN |
| SECONDARY | Bilirubin - Percent Change From Baseline | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 | Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose | Percent Change | MEDIAN |
| OTHER_PRE_SPECIFIED | Serum Creatinine (sCR) | Baseline (Screening or Day 1 Pre-dose) | Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. | mg/dL | MEDIAN |
Source ClinicalTrials.gov
Results by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lille Model for Alcoholic Hepatitis Score | Moderate AH DUR-928 30 mg | 0.020 | Full Range 0.01 to 0.04 | score on a scale | |
| Lille Model for Alcoholic Hepatitis Score | Moderate AH DUR-928 90 mg | 0.050 | Full Range 0.01 to 0.05 | score on a scale | |
| Lille Model for Alcoholic Hepatitis Score | Severe AH DUR-928 30 mg | 0.155 | Full Range 0.05 to 0.19 | score on a scale | |
| Lille Model for Alcoholic Hepatitis Score | Severe AH DUR-928 90 mg | 0.195 | Full Range 0.04 to 0.24 | score on a scale | |
| Lille Model for Alcoholic Hepatitis Score | Severe AH DUR-928 150 mg | 0.420 | Full Range 0.08 to 0.87 | score on a scale | |
| Model for End Stage Liver Disease (MELD) Score | Moderate AH DUR-928 30 mg | Screening | 19.5 | Full Range 15 to 20 | score on a scale |
| Model for End Stage Liver Disease (MELD) Score | Moderate AH DUR-928 90 mg | Screening | 19.0 | Full Range 14 to 21 | score on a scale |
| Model for End Stage Liver Disease (MELD) Score | Severe AH DUR-928 30 mg | Screening | 24.5 | Full Range 21 to 28 | score on a scale |
| Model for End Stage Liver Disease (MELD) Score | Severe AH DUR-928 90 mg | Screening | 24.5 | Full Range 21 to 28 | score on a scale |
| Model for End Stage Liver Disease (MELD) Score | Severe AH DUR-928 150 mg | Screening | 25.0 | Full Range 23 to 27 | score on a scale |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moderate AH DUR-928 30 mg | 4 | |
| Overall Study | STARTED | Moderate AH DUR-928 90 mg | 3 | |
| Overall Study | STARTED | Severe AH DUR-928 30 mg | 4 | |
| Overall Study | STARTED | Severe AH DUR-928 90 mg | 4 | |
| Overall Study | STARTED | Severe AH DUR-928 150 mg | 4 | |
| Overall Study | COMPLETED | Moderate AH DUR-928 30 mg | 3 | |
| Overall Study | COMPLETED | Moderate AH DUR-928 90 mg | 2 | |
| Overall Study | COMPLETED | Severe AH DUR-928 30 mg | 4 | |
| Overall Study | COMPLETED | Severe AH DUR-928 90 mg | 4 | |
| Overall Study | COMPLETED | Severe AH DUR-928 150 mg | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events135
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Moderate AH DUR-928 30 mg | 1 | 4 | |
| other | Nausea | Gastrointestinal disorders | Moderate AH DUR-928 90 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Severe AH DUR-928 30 mg | 1 | 4 | |
| other | Nausea | Gastrointestinal disorders | Severe AH DUR-928 90 mg | 0 | 4 | |
| other | Nausea | Gastrointestinal disorders | Severe AH DUR-928 150 mg | 2 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Moderate AH DUR-928 30 mg | 0 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Moderate AH DUR-928 90 mg | 0 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Severe AH DUR-928 30 mg | 2 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Severe AH DUR-928 90 mg | 0 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Severe AH DUR-928 150 mg | 0 | 4 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moderate AH DUR-928 30 mg | 0 | 4 |
| Total, all-cause mortality | Moderate AH DUR-928 90 mg | 0 | 3 |
| Total, all-cause mortality | Severe AH DUR-928 30 mg | 0 | 4 |
| Total, all-cause mortality | Severe AH DUR-928 90 mg | 0 | 4 |
| Total, all-cause mortality | Severe AH DUR-928 150 mg | 0 | 4 |
| Total, other adverse events | Moderate AH DUR-928 30 mg | 4 | 4 |
| Total, other adverse events | Moderate AH DUR-928 90 mg | 2 | 3 |
| Total, other adverse events | Severe AH DUR-928 30 mg | 3 | 4 |
| Total, other adverse events | Severe AH DUR-928 90 mg | 3 | 4 |
| Total, other adverse events | Severe AH DUR-928 150 mg | 3 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37011138 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03432260
GET https://conductscience.org/api/trials/v1/NCT03432260/results?page=2