Trial · NCT02230683

A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension

NCT02230683, Phase 2, Completed, Conatus Pharmaceuticals Inc.; results first posted 2016-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension. Trials, record NCT02230683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02230683

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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 Cirrhotic Subjects With Portal Hypertension
NCT number: NCT02230683
Status: Completed
Phases: Phase 2
Enrollment: 23 participants, actual
Lead sponsor: Conatus Pharmaceuticals Inc.
Conditions: Liver Cirrhosis, Hepatic Cirrhosis, Portal Hypertension
Interventions: IDN-6556
First posted: 2014-09-03
Last updated: 2016-12-21
Results first posted: 2016-12-21

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hepatic Venous Pressure Gradient (HVPG)	Baseline to Day 28/EOT (end of treatment)	Mean change of HVPG \[mmHg\] from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Primary	cCK18/M30	Change from Baseline to Day 28/EOT	Absolute Mean Change of caspase-cleaved cytokeratin serum levels (cCK18/M30); the statistical analysis is based on the mean change in log-transformed cCK18/M30 from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Primary	Change in cCK18/M30	Baseline to Day 28/EOT (end of treatment)	Median change of caspase-cleaved cytokeratin serum levels (cCK18/M30) from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Secondary	Change in Alanine Aminotransferase (ALT)	Baseline to 28 days/EOT	Median change of ALT from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Secondary	Change in Aspartate Aminotransferase (AST)	Baseline to 28 days/EOT	Median change of AST from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Secondary	Concentration of Caspase 3/7 RLU	Baseline to 28 days/EOT	Median change of concentration of Caspase 3/7 Relative Light Units from Baseline to Day 28/EOT (end of treatment) for IDN-6556

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	Hepatic Venous Pressure Gradient (HVPG)	Baseline to Day 28/EOT (end of treatment)	23 subjects were enrolled, of whom 22 were evaluable for the HVPG endpoint. 1 subject discontinued at day 1.	mmHg	MEAN
PRIMARY	cCK18/M30	Change from Baseline to Day 28/EOT		U/L	MEAN
PRIMARY	Change in cCK18/M30	Baseline to Day 28/EOT (end of treatment)		U/L	MEDIAN
SECONDARY	Change in Alanine Aminotransferase (ALT)	Baseline to 28 days/EOT		U/L	MEDIAN
SECONDARY	Change in Aspartate Aminotransferase (AST)	Baseline to 28 days/EOT		U/L	MEDIAN
SECONDARY	Concentration of Caspase 3/7 RLU	Baseline to 28 days/EOT		RLU	MEDIAN

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Category	Value	Spread	Units
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Overall Population	Baseline	15.2	Standard Deviation 7.68	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Subgroup With HVPG < 12 mmHg	Baseline	8.05	Standard Deviation 1.88	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Subgroup HVPG ≥ 12 mmHg	Baseline	20.62	Standard Deviation 5.59	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Overall Population	Day 28/EOT	14.1	Standard Deviation 6.40	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Subgroup With HVPG < 12 mmHg	Day 28/EOT	10.0	Standard Deviation 3.86	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Subgroup HVPG ≥ 12 mmHg	Day 28/EOT	17.6	Standard Deviation 6.10	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Overall Population	Change From Baseline	-1.14	Standard Deviation 4.57	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Subgroup With HVPG < 12 mmHg	Change From Baseline	1.90	Standard Deviation 3.15	mmHg
Hepatic Venous Pressure Gradient (HVPG)	IDN-6556 - Subgroup HVPG ≥ 12 mmHg	Change From Baseline	-3.67	Standard Deviation 4.05	mmHg
cCK18/M30	IDN-6556 - Overall Population		-47.1	Standard Deviation 122.23	U/L

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	IDN-6556	23
Overall Study	COMPLETED	IDN-6556	22
Overall Study	NOT COMPLETED	IDN-6556	1

Source ClinicalTrials.gov

Adverse events47

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	Anaemia	Blood and lymphatic system disorders	IDN-6556	1	23	2
other	Ventricular extrasystoles	Cardiac disorders	IDN-6556	1	23	1
other	Ear congestion	Ear and labyrinth disorders	IDN-6556	1	23	1
other	Abdominal disorders	Gastrointestinal disorders	IDN-6556	1	23	1
other	Constipation	Gastrointestinal disorders	IDN-6556	2	23	2
other	Diarrhoea	Gastrointestinal disorders	IDN-6556	2	23	3
other	Dry mouth	Gastrointestinal disorders	IDN-6556	1	23	1
other	Mouth ulceration	Gastrointestinal disorders	IDN-6556	1	23	1
other	Nausea	Gastrointestinal disorders	IDN-6556	2	23	2
other	Oral pain	Gastrointestinal disorders	IDN-6556	1	23	1

1 to 10 of 47Source ClinicalTrials.gov

See all 47 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IDN-6556
Total, other adverse events	IDN-6556	15	23
Total, serious adverse events	IDN-6556	1	23

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 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.

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.

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