Trial · NCT02230670
A Study of IDN-6556 in Subjects With Liver Cirrhosis
NCT02230670, Phase 2, Completed, Conatus Pharmaceuticals Inc.; results first posted 2017-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of IDN-6556 in Subjects With Liver Cirrhosis. Trials, record NCT02230670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02230670
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of IDN-6556 in Subjects With Liver Cirrhosis
- NCT number
- NCT02230670
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Conditions
- Liver Cirrhosis, Hepatic Cirrhosis
- Interventions
- IDN-6556, Placebo
- First posted
- 2014-09-03
- Last updated
- 2017-07-05
- Results first posted
- 2017-07-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Month 3 in cCK18/M30 | 3 months | Baseline, Month 3, and change between for cCK18/M30 |
| Primary | Change From Baseline at Month 3 in cCK18/M30 | 3 months | Data was log-transformed for analysis purposes |
| Secondary | Change From Baseline to Month 3 in MELD Score | 3 Months | The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43 MELD scores are reported as whole numbers, so the result of the equation above is rounded. Notes: If the patient has been dialyzed twice within the last 7 days, then the value for serum creatinine used should be 4.0. Any value less than one is given a value of 1 (i.e. if bilirubin is 0.8, a value of 1.0 is used) to prevent the occurrence of scores below 0 (the natural logarithm of 1 is 0, and any value below 1 would yield a negative result). The higher the MELD score the more severe the disease state. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Month 3 in cCK18/M30 | 3 months | FAS | U/L | MEDIAN |
| PRIMARY | Change From Baseline at Month 3 in cCK18/M30 | 3 months | Full analysis set | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 3 in MELD Score | 3 Months | FAS | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Month 3 in cCK18/M30 | IDN-6556 | Baseline | 293.5 | Full Range 66 to 1857 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | Placebo | Baseline | 257.5 | Full Range 104 to 6994 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | IDN-6556 | Month 3 | 288.5 | Full Range 39 to 1583 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | Placebo | Month 3 | 285.0 | Full Range 115 to 19710 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | IDN-6556 | Log-transformed Values | -0.049 | Standard Error 0.057 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | Placebo | Log-transformed Values | 0.090 | Standard Error 0.058 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | IDN-6556 | Percent (%) Relative Change | -4.6 | Standard Error 5.9 | U/L |
| Change From Baseline at Month 3 in cCK18/M30 | Placebo | Percent (%) Relative Change | 9.3 | Standard Error 5.9 | U/L |
| Change From Baseline to Month 3 in MELD Score | IDN-6556 | -0.10 | Standard Error 0.234 | units on a scale | |
| Change From Baseline to Month 3 in MELD Score | Placebo | 0.15 | Standard Error 0.239 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IDN-6556 | 44 | |
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | COMPLETED | IDN-6556 | 40 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | IDN-6556 | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events58
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 | abdominal pain | Gastrointestinal disorders | IDN-6556 (Baseline-Month 3) | 3 | 44 | 3 |
| other | abdominal pain | Gastrointestinal disorders | Placebo (Baseline-Month 3) | 3 | 42 | 3 |
| other | arthralgia | General disorders | IDN-6556 (Baseline-Month 3) | 3 | 44 | 3 |
| other | arthralgia | General disorders | Placebo (Baseline-Month 3) | 0 | 42 | 0 |
| other | ascites | Gastrointestinal disorders | IDN-6556 (Baseline-Month 3) | 1 | 44 | 2 |
| other | ascites | Gastrointestinal disorders | Placebo (Baseline-Month 3) | 3 | 42 | 3 |
| other | fatigue | Metabolism and nutrition disorders | IDN-6556 (Baseline-Month 3) | 4 | 44 | 4 |
| other | fatigue | Metabolism and nutrition disorders | Placebo (Baseline-Month 3) | 6 | 42 | 7 |
| other | headache | Nervous system disorders | IDN-6556 (Baseline-Month 3) | 7 | 44 | 8 |
| other | headache | Nervous system disorders | Placebo (Baseline-Month 3) | 3 | 42 | 4 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDN-6556 (Baseline-Month 3) | 0 | 44 |
| Total, all-cause mortality | Placebo (Baseline-Month 3) | 0 | 42 |
| Total, other adverse events | IDN-6556 (Baseline-Month 3) | 34 | 44 |
| Total, other adverse events | Placebo (Baseline-Month 3) | 30 | 42 |
| Total, serious adverse events | IDN-6556 (Baseline-Month 3) | 6 | 44 |
| Total, serious adverse events | Placebo (Baseline-Month 3) | 5 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29913280 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IDN-6556 (Baseline-Month 3) vs Placebo (Baseline-Month 3): deaths from any cause | Trial comparisons |
| IDN-6556 (Baseline-Month 3) vs Placebo (Baseline-Month 3): 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/NCT02230670
GET https://conductscience.org/api/trials/v1/NCT02230670/events?page=2