Trial · NCT02854631
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
NCT02854631, Phase 2, Completed, Gilead Sciences; results first posted 2019-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH). Trials, record NCT02854631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02854631
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
- NCT number
- NCT02854631
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Alcoholic Hepatitis (AH)
- Interventions
- Selonsertib, Prednisolone, Placebo
- First posted
- 2016-08-03
- Last updated
- 2019-02-06
- Other registries' IDs
- eudract:2016-000821-37
- Results first posted
- 2019-02-06
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Up to Day 28 plus 30 days | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. |
| Secondary | Percentage of Participants Who Died by Day 28 | Day 28 | The percentage of participants who died by Day 28 was calculated. |
| Secondary | Percentage of Participants Who Died by Week 8 | Week 8 | The percentage of participants who died by Week 8 was calculated. |
| Secondary | Percentage of Participants Who Died by Week 12 | Week 12 | The percentage of participants who died by Week 12 was calculated. |
| Secondary | Percentage of Participants Who Died by Week 24 | Week 24 | The percentage of participants who died by Week 24 was calculated. |
| Secondary | Percentage of Participants With Survival at Day 28 Using Kaplan-Meier | Day 28 | The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants With Survival at Week 8 Using Kaplan-Meier | Week 8 | The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants With Survival at Week 12 Using Kaplan-Meier | Week 12 | The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants With Survival at Week 24 Using Kaplan-Meier | Week 24 | The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants Who Received a Liver Transplant | Day 28, Week 8, Week 12, and Week 24 | The percentage of participants who received a liver transplant by week 24 was calculated. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Up to Day 28 plus 30 days | Safety Analysis Set included participants who were randomized and took at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died by Day 28 | Day 28 | Participants in the Full Analysis Set (participants who took at least 1 dose of study drug, and had histologically-confirmed severe alcoholic hepatitis (AH)) with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died by Week 8 | Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died by Week 12 | Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died by Week 24 | Week 24 | Participants in the Full Analysis Set with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Survival at Day 28 Using Kaplan-Meier | Day 28 | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Survival at Week 8 Using Kaplan-Meier | Week 8 | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Survival at Week 12 Using Kaplan-Meier | Week 12 | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Survival at Week 24 Using Kaplan-Meier | Week 24 | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received a Liver Transplant | Day 28, Week 8, Week 12, and Week 24 | Participants in the Full Analysis Set with available data were analyzed. | Percentage of participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group258
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Selonsertib + Prednisolone | TEAEs | 94.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Placebo + Prednisolone | TEAEs | 94.2 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Selonsertib + Prednisolone | TE SAEs | 50.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Placebo + Prednisolone | TE SAEs | 40.4 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Selonsertib + Prednisolone | TEAEs (discontinuation of Selonsertib/Placebo) | 18.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Placebo + Prednisolone | TEAEs (discontinuation of Selonsertib/Placebo) | 7.7 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Selonsertib + Prednisolone | TEAEs (discontinuation of Prednisolone) | 14.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Placebo + Prednisolone | TEAEs (discontinuation of Prednisolone) | 11.5 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Selonsertib + Prednisolone | TEAEs (discontinuation of both drugs in regimen) | 14.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Placebo + Prednisolone | TEAEs (discontinuation of both drugs in regimen) | 7.7 | Percentage of participants |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selonsertib + Prednisolone | 52 | |
| Overall Study | STARTED | Placebo + Prednisolone | 52 | |
| Overall Study | COMPLETED | Selonsertib + Prednisolone | 26 | |
| Overall Study | COMPLETED | Placebo + Prednisolone | 37 | |
| Overall Study | NOT COMPLETED | Selonsertib + Prednisolone | 26 | |
| Overall Study | NOT COMPLETED | Placebo + Prednisolone | 15 |
Source ClinicalTrials.gov
Adverse events192
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 | Leukocytosis | Blood and lymphatic system disorders | Selonsertib + Prednisolone | 4 | 50 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo + Prednisolone | 2 | 52 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Selonsertib + Prednisolone | 4 | 50 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo + Prednisolone | 1 | 52 | |
| other | Ascites | Gastrointestinal disorders | Selonsertib + Prednisolone | 15 | 50 | |
| other | Ascites | Gastrointestinal disorders | Placebo + Prednisolone | 14 | 52 | |
| other | Constipation | Gastrointestinal disorders | Selonsertib + Prednisolone | 6 | 50 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Prednisolone | 5 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | Selonsertib + Prednisolone | 4 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Prednisolone | 4 | 52 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selonsertib + Prednisolone | 14 | 50 |
| Total, all-cause mortality | Placebo + Prednisolone | 9 | 52 |
| Total, other adverse events | Selonsertib + Prednisolone | 43 | 50 |
| Total, other adverse events | Placebo + Prednisolone | 42 | 52 |
| Total, serious adverse events | Selonsertib + Prednisolone | 25 | 50 |
| Total, serious adverse events | Placebo + Prednisolone | 21 | 52 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Selonsertib + Prednisolone vs Placebo + Prednisolone: deaths from any cause | Trial comparisons |
| Selonsertib + Prednisolone vs Placebo + Prednisolone: serious adverse events | Trial comparisons |
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/NCT02854631
GET https://conductscience.org/api/trials/v1/NCT02854631/registered?page=2