Trial · NCT01937130
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
NCT01937130, Phase 2, Terminated, Conatus Pharmaceuticals Inc.; results first posted 2016-04-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF. Trials, record NCT01937130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01937130
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
- NCT number
- NCT01937130
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Conditions
- Acute on Chronic Hepatic Failure, Acute Liver Failure, Liver Cirrhosis, Acute Alcoholic Hepatitis
- Interventions
- IDN-6556, Placebo
- First posted
- 2013-09-09
- Last updated
- 2016-04-11
- Results first posted
- 2016-04-11
- Limitations and caveats
- Study was terminated early.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) | 28 days | Primary endpoints for AUC\_0-8, AUC\_0 last, AUC\_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed. |
| Primary | Cmax | 28 Days | Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed. |
| Primary | Tmax & t1/2 Parameters | 28 Days | Primary endpoints for tmax \& t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed. |
| Secondary | Levels of CK18/M30 | Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28 | Caspase-cleaved cytokeratin serum levels (CK18/M30) |
| Secondary | Levels of CK18/M65 | Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28 | Caspase full-length cytokeratin serum levels CK18/M65 |
| Secondary | Levels of Caspase 3/7 RLU | Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28 | Concentration of Caspase 3/7 Relative Light Units |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) | 28 days | AUC\_0-last: The number of participants analyzed in the 25mg arm was 7 at Day 1 AUC\_0-inf: The number of participants analyzed in the 5mg arm was 2 at Day 1 and 0 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax | 28 Days | (ng/mL) | GEOMETRIC_MEAN | |
| PRIMARY | Tmax & t1/2 Parameters | 28 Days | t1/2 number of participants analyzed at Day 1 in the 5mg arm was 2 and 1 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values. | (h) | MEAN |
| SECONDARY | Levels of CK18/M30 | Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28 | Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values | U/L | MEDIAN |
| SECONDARY | Levels of CK18/M65 | Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28 | Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values | U/L | MEDIAN |
| SECONDARY | Levels of Caspase 3/7 RLU | Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28 | Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values | RLU | MEDIAN |
Source ClinicalTrials.gov
Results by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC) | IDN-6556 5 mg | Day 1 AUC 0-8 | 275 | Geometric Coefficient of Variation 40.0 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 25 mg | Day 1 AUC 0-8 | 1165 | Geometric Coefficient of Variation 45.3 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 50 mg | Day 1 AUC 0-8 | 2397 | Geometric Coefficient of Variation 99.3 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 5 mg | Day 4 AUC 0-8 | 224.3 | Geometric Coefficient of Variation 36.9 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 25 mg | Day 4 AUC 0-8 | 1767 | Geometric Coefficient of Variation 31.4 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 50 mg | Day 4 AUC 0-8 | 2148 | Geometric Coefficient of Variation 227.9 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 5 mg | Day 1 AUC 0-last | 275 | Geometric Coefficient of Variation 40.0 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 25 mg | Day 1 AUC 0-last | 1295 | Geometric Coefficient of Variation 33.4 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 50 mg | Day 1 AUC 0-last | 2997 | Geometric Coefficient of Variation 103.8 | h*ng/mL |
| Area Under the Curve (AUC) | IDN-6556 5 mg | Day 4 AUC 0-last | 224.3 | Geometric Coefficient of Variation 36.9 | h*ng/mL |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IDN-6556 5 mg | 5 | |
| Overall Study | STARTED | IDN-6556 25 mg | 7 | |
| Overall Study | STARTED | IDN-6556 50 mg | 5 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | IDN-6556 5 mg | 0 | |
| Overall Study | COMPLETED | IDN-6556 25 mg | 3 | |
| Overall Study | COMPLETED | IDN-6556 50 mg | 2 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | IDN-6556 5 mg | 5 | |
| Overall Study | NOT COMPLETED | IDN-6556 25 mg | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events140
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 | Blood and lymphatic system disorders | Blood and lymphatic system disorders | IDN-6556 5 mg | 0 | 5 | |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | IDN-6556 25 mg | 1 | 7 | |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | IDN-6556 50 mg | 1 | 5 | |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Placebo | 0 | 4 | |
| other | Cardiac disorders | Cardiac disorders | IDN-6556 5 mg | 1 | 5 | |
| other | Cardiac disorders | Cardiac disorders | IDN-6556 25 mg | 1 | 7 | |
| other | Cardiac disorders | Cardiac disorders | IDN-6556 50 mg | 0 | 5 | |
| other | Cardiac disorders | Cardiac disorders | Placebo | 0 | 4 | |
| other | Eye disorders | Eye disorders | IDN-6556 5 mg | 0 | 5 | |
| other | Eye disorders | Eye disorders | IDN-6556 25 mg | 1 | 7 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDN-6556 5 mg | ||
| Total, all-cause mortality | IDN-6556 25 mg | ||
| Total, all-cause mortality | IDN-6556 50 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | IDN-6556 5 mg | 3 | 5 |
| Total, other adverse events | IDN-6556 25 mg | 7 | 7 |
| Total, other adverse events | IDN-6556 50 mg | 4 | 5 |
| Total, other adverse events | Placebo | 3 | 4 |
| Total, serious adverse events | IDN-6556 5 mg | 3 | 5 |
| Total, serious adverse events | IDN-6556 25 mg | 6 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT01937130
GET https://conductscience.org/api/trials/v1/NCT01937130/results?page=2