Clinical trial · Interventional
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
NCT00080236CI-TRIAL-00007816completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholestasis | — | UNRESOLVED | — |
| Hepatitis | — | UNRESOLVED | — |
| Liver Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDN-6556 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- Donor organ placebo and Recipient placebo
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo
- interventionNames
- Drug: IDN-6556
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg
- interventionNames
- Drug: IDN-6556
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Minimum adult age Exclusion Criteria: * Fulminant hepatic failure (UNOS Status I patients) * Previous liver transplantation * Patients undergoing split liver grafts * Extrahepatic malignancy * If female, pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.