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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryChange From Baseline at Month 3 in cCK18/M303 monthsBaseline, Month 3, and change between for cCK18/M30
PrimaryChange From Baseline at Month 3 in cCK18/M303 monthsData was log-transformed for analysis purposes
SecondaryChange From Baseline to Month 3 in MELD Score3 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.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline at Month 3 in cCK18/M303 monthsFASU/LMEDIAN
PRIMARYChange From Baseline at Month 3 in cCK18/M303 monthsFull analysis setU/LLEAST_SQUARES_MEAN
SECONDARYChange From Baseline to Month 3 in MELD Score3 MonthsFASunits on a scaleLEAST_SQUARES_MEAN

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline at Month 3 in cCK18/M30IDN-6556Baseline293.5Full Range 66 to 1857U/L
Change From Baseline at Month 3 in cCK18/M30PlaceboBaseline257.5Full Range 104 to 6994U/L
Change From Baseline at Month 3 in cCK18/M30IDN-6556Month 3288.5Full Range 39 to 1583U/L
Change From Baseline at Month 3 in cCK18/M30PlaceboMonth 3285.0Full Range 115 to 19710U/L
Change From Baseline at Month 3 in cCK18/M30IDN-6556Log-transformed Values-0.049Standard Error 0.057U/L
Change From Baseline at Month 3 in cCK18/M30PlaceboLog-transformed Values0.090Standard Error 0.058U/L
Change From Baseline at Month 3 in cCK18/M30IDN-6556Percent (%) Relative Change-4.6Standard Error 5.9U/L
Change From Baseline at Month 3 in cCK18/M30PlaceboPercent (%) Relative Change9.3Standard Error 5.9U/L
Change From Baseline to Month 3 in MELD ScoreIDN-6556-0.10Standard Error 0.234units on a scale
Change From Baseline to Month 3 in MELD ScorePlacebo0.15Standard Error 0.239units on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIDN-655644
Overall StudySTARTEDPlacebo42
Overall StudyCOMPLETEDIDN-655640
Overall StudyCOMPLETEDPlacebo34
Overall StudyNOT COMPLETEDIDN-65564
Overall StudyNOT COMPLETEDPlacebo8

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherabdominal painGastrointestinal disordersIDN-6556 (Baseline-Month 3)3443
otherabdominal painGastrointestinal disordersPlacebo (Baseline-Month 3)3423
otherarthralgiaGeneral disordersIDN-6556 (Baseline-Month 3)3443
otherarthralgiaGeneral disordersPlacebo (Baseline-Month 3)0420
otherascitesGastrointestinal disordersIDN-6556 (Baseline-Month 3)1442
otherascitesGastrointestinal disordersPlacebo (Baseline-Month 3)3423
otherfatigueMetabolism and nutrition disordersIDN-6556 (Baseline-Month 3)4444
otherfatigueMetabolism and nutrition disordersPlacebo (Baseline-Month 3)6427
otherheadacheNervous system disordersIDN-6556 (Baseline-Month 3)7448
otherheadacheNervous system disordersPlacebo (Baseline-Month 3)3424

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIDN-6556 (Baseline-Month 3)044
Total, all-cause mortalityPlacebo (Baseline-Month 3)042
Total, other adverse eventsIDN-6556 (Baseline-Month 3)3444
Total, other adverse eventsPlacebo (Baseline-Month 3)3042
Total, serious adverse eventsIDN-6556 (Baseline-Month 3)644
Total, serious adverse eventsPlacebo (Baseline-Month 3)542

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
29913280DERIVED

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.

ComparisonSource
IDN-6556 (Baseline-Month 3) vs Placebo (Baseline-Month 3): deaths from any causeTrial comparisons
IDN-6556 (Baseline-Month 3) vs Placebo (Baseline-Month 3): serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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