Trial · NCT01912404
Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
NCT01912404, Phase 2, Terminated, Conatus Pharmaceuticals Inc.; results first posted 2016-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy. Trials, record NCT01912404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01912404
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
- NCT number
- NCT01912404
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Conditions
- Alcoholic Hepatitis
- Interventions
- IDN-6556, Placebo
- First posted
- 2013-07-31
- Last updated
- 2016-11-04
- Results first posted
- 2016-11-04
- Limitations and caveats
- Since the study was stopped early, no conclusions regarding efficacy can be made.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival | 28 days |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival | 28 days | The study was prematurely stopped due to emerging data from another study showing \~10 to 12-fold higher exposures in patients with severe hepatic impairment compared to those with normal liver function. Since subjects with alcoholic hepatitis would likely have severe hepatic impairment, the study was stopped and survival data was not collected. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IDN-6556 | 3 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | COMPLETED | IDN-6556 | 2 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | IDN-6556 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events46
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 | Diarrhoea | Gastrointestinal disorders | IDN-6556 | 2 | 3 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 2 | 2 |
| other | Hypokalaemia | Metabolism and nutrition disorders | IDN-6556 | 2 | 3 | 2 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo | 2 | 2 | 3 |
| other | Constipation | Gastrointestinal disorders | IDN-6556 | 2 | 3 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 2 | 2 |
| other | Gastrointestinal haemorrhage | Gastrointestinal disorders | IDN-6556 | 1 | 3 | 1 |
| other | Gastrointestinal haemorrhage | Gastrointestinal disorders | Placebo | 2 | 2 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | IDN-6556 | 1 | 3 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 2 | 4 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDN-6556 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | IDN-6556 | 3 | 3 |
| Total, other adverse events | Placebo | 2 | 2 |
| Total, serious adverse events | IDN-6556 | 3 | 3 |
| Total, serious adverse events | Placebo | 2 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AA021788 | Liquid biopsy for alcoholic hepatitis: diagnosis, prognosis and technology development | SHAH, VIJAY H.; MALHI, HARMEET | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2012 to 2022 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IDN-6556 vs Placebo: serious adverse events |
Source 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/NCT01912404
GET https://conductscience.org/api/trials/v1/NCT01912404/events?page=2