Trial · NCT02138253
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
NCT02138253, Phase 2, Completed, Conatus Pharmaceuticals Inc.; results first posted 2019-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV. Trials, record NCT02138253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02138253
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
- NCT number
- NCT02138253
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Interventions
- IDN-6556, Placebo
- First posted
- 2014-05-14
- Last updated
- 2019-12-11
- Results first posted
- 2019-12-11
- Limitations and caveats
The broad range of fibrosis stages included in the study and the high placebo response rates especially in the F2 and F6 fibrosis stages impacted the primary endpoint of improvement in fibrosis score from baseline.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | 24 months | At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite Since the primary analysis used multiple imputation methodology, the numerator and denominator varied across 20 imputations. |
| Secondary | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only) | 24 months | At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite |
| Secondary | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | 12 months | At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite |
| Secondary | Alanine Aminotransferase (ALT) - Change From Baseline | Baseline and 24 months | Liver function laboratory parameter |
| Secondary | Aspartate Aminotransferase (AST) Change From Baseline | Baseline and 24 months | Liver function laboratory parameter |
| Secondary | Caspase 3/7 Change From Baseline | Baseline and 24 months | Mechanistic biomarker of liver function |
| Secondary | cCK18/M30 Change From Baseline | Baseline and 24 months | Mechanistic biomarker of liver function. |
| Secondary | flCK18/M65 Change From Baseline | Baseline and 24 months | Mechanistic biomarker of liver function |
| Secondary | Ishak Modification of Knodell Histological Activity Index - Interface Hepatitis | 24 months | The Ishak modification of Knodell histological activity index was determined by liver biopsy. Interface hepatitis * 0 = None * 1 = Mild (local, few portal areas) * 2 = Mild/moderate (focal, most portal areas) * 3 = Moderate (continuous around \<50% of tracts or septa) * 4 = Severe (continuous around \>50% of tracts or septa) |
| Secondary | Ishak Modification of Knodell Histological Index - Confluent Necrosis | 24 months | The Ishak modification of Knodell histological activity index will be determined by liver biopsy. The four items and their categorizations scores include: • confluent necrosis * 0 = None * 1 = Focal confluent necrosis * 2 = Zone 3 necrosis in some areas * 3 = Zone 3 necrosis in most areas * 4 = Zone 3 necrosis + occasional portal-central bridging * 5 = Zone 3 necrosis + multiple portal-central bridging * 6 = Panacinar or multiacinar necrosis |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | 24 months | The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only) | 24 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | 12 months | Full analysis set, the # of subject analyzed included subjects with an observed Ishak Fibrosis Score at 12 months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Alanine Aminotransferase (ALT) - Change From Baseline | Baseline and 24 months | Full analysis set, the # of subject analyzed included subjects with an observed ALT at 24 months. | U/L | MEAN |
| SECONDARY | Aspartate Aminotransferase (AST) Change From Baseline | Baseline and 24 months | Full analysis set, the # of subject analyzed included subjects with an observed AST at 24 months. | U/L | MEAN |
| SECONDARY | Caspase 3/7 Change From Baseline | Baseline and 24 months | Full analysis set, the # of subject analyzed included subjects with an observed Caspase 3/7 at 24 months. | Raw RLU | MEAN |
| SECONDARY | cCK18/M30 Change From Baseline | Baseline and 24 months | Full analysis set, the # of subject analyzed included subjects with an observed cCK18/M30 at 24 months. | U/L | MEAN |
| SECONDARY | flCK18/M65 Change From Baseline | Baseline and 24 months | Full analysis set, the # of subject analyzed included subjects with an observed flCK18/M65 at 24 months. | U/L | MEAN |
| SECONDARY | Ishak Modification of Knodell Histological Activity Index - Interface Hepatitis | 24 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ishak Modification of Knodell Histological Index - Confluent Necrosis | 24 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | IDN-6556 | 25 | participants | ||
| Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | Placebo | 14 | participants | ||
| Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only) | IDN-6556 | 25 | Participants | ||
| Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only) | Placebo | 14 | Participants | ||
| Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | IDN-6556 | 27 | Participants | ||
| Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | Placebo | 17 | Participants | ||
| Alanine Aminotransferase (ALT) - Change From Baseline | IDN-6556 | -3.7 | Standard Deviation 10 | U/L | |
| Alanine Aminotransferase (ALT) - Change From Baseline | Placebo | 43.7 | Standard Deviation 239.5 | U/L | |
| Aspartate Aminotransferase (AST) Change From Baseline | IDN-6556 | -4.0 | Standard Deviation 8.5 | U/L | |
| Aspartate Aminotransferase (AST) Change From Baseline | Placebo | 31.4 | Standard Deviation 161.8 | U/L |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IDN-6556 | 41 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | IDN-6556 | 32 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | IDN-6556 | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events14
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 | Diarrhea | Gastrointestinal disorders | IDN-6556 | 9 | 41 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 5 | 23 | 6 |
| other | Hypertension | Vascular disorders | IDN-6556 | 6 | 41 | 7 |
| other | Hypertension | Vascular disorders | Placebo | 4 | 23 | 9 |
| other | Nausea | Gastrointestinal disorders | IDN-6556 | 7 | 41 | 10 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 23 | 11 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | IDN-6556 | 6 | 41 | 10 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 2 | 23 | 7 |
| other | Fatigue | General disorders | IDN-6556 | 8 | 41 | 8 |
| other | Fatigue | General disorders | Placebo | 6 | 23 | 7 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDN-6556 | 0 | 41 |
| Total, all-cause mortality | Placebo | 1 | 23 |
| Total, other adverse events | IDN-6556 | 37 | 41 |
| Total, other adverse events | Placebo | 20 | 23 |
| Total, serious adverse events | IDN-6556 | 0 | 41 |
| Total, serious adverse events | Placebo | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IDN-6556 vs Placebo: Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | Trial comparisons |
| IDN-6556 vs Placebo: Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | Trial comparisons |
| IDN-6556 vs Placebo: deaths from any cause | Trial comparisons |
| IDN-6556 vs Placebo: Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only) | Trial comparisons |
| IDN-6556 vs Placebo: 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/NCT02138253
GET https://conductscience.org/api/trials/v1/NCT02138253/results?page=2