Drug-Induced Liver Injury (DILI) Network Retrospective (ILIAD)
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| ClinicalTrials.gov Identifier: NCT00360646 |
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Recruitment Status :
Recruiting
First Posted : August 4, 2006
Last Update Posted : April 3, 2024
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| Tracking Information | |||||||||
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| First Submitted Date | August 2, 2006 | ||||||||
| First Posted Date | August 4, 2006 | ||||||||
| Last Update Posted Date | April 3, 2024 | ||||||||
| Actual Study Start Date | September 2004 | ||||||||
| Estimated Primary Completion Date | July 31, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
maintain a registry of cases in the ILIAD database [ Time Frame: July 2028 ] maintain a registry of cases in the ILIAD database
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| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Drug-Induced Liver Injury (DILI) Network Retrospective | ||||||||
| Official Title | Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study | ||||||||
| Brief Summary | The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI and the relevant clinical data concerning the episode of DILI; and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as living immune cells for phenotyping studies. A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be recontacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI. |
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| Detailed Description | Drug-induced liver injury (DILI) is the single most common reason for regulatory actions concerning drugs, including failure to gain approval for marketing, removal from the market place, and restriction of prescribing indications. DILI is also a significant cause of morbidity and mortality in many patient populations. To stimulate and facilitate research into DILI, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has recently established the Drug-Induced Liver Injury Network (DILIN). One of the initial projects to be conducted by the network is to retrospectively establish a nationwide registry of patients who have suffered severe idiosyncratic liver injury associated with any drugs (ILIAD) and HDS agents, and to collect, immortalize and store serum, DNA, and lymphocytes from these patients (hereafter referred to as the "ILIAD protocol"). This ILIAD protocol will serve as a resource for subsequent mechanistic investigations of the basis for susceptibility to severe idiosyncratic DILI. The network will initially identify people who have developed DILI onset beyond 6 months of enrollment due to all drugs or HDS/CAM cases that did not meet the entrance criteria for the Prospective study. The specific aims are as follows:
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Samples with DNA
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with liver injury ascribed to any drug or HDS/CAM agent which the DILI onset date occurred beyond six months from enrollment. | ||||||||
| Condition | Drug Induced Liver Injury | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Rochon J, Protiva P, Seeff LB, Fontana RJ, Liangpunsakul S, Watkins PB, Davern T, McHutchison JG; Drug-Induced Liver Injury Network (DILIN). Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology. 2008 Oct;48(4):1175-83. doi: 10.1002/hep.22442. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
400 | ||||||||
| Original Enrollment |
200 | ||||||||
| Estimated Study Completion Date | July 31, 2028 | ||||||||
| Estimated Primary Completion Date | July 31, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria: Screening Criteria To be included in the ILIAD registry, the following criteria must be satisfied:
Exclusion Criteria: Subjects will be excluded according to the following criteria:
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| Sex/Gender |
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| Ages | 2 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT00360646 | ||||||||
| Other Study ID Numbers | Pro00113362 2U01DK065176-21 ( U.S. NIH Grant/Contract ) Pro00072297 ( Other Identifier: Advarra ) Pro00017208 ( Other Identifier: original Duke IRB number ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Duke University | ||||||||
| Original Responsible Party | Not Provided | ||||||||
| Current Study Sponsor | Duke University | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Investigators |
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| PRS Account | Duke University | ||||||||
| Verification Date | April 2024 | ||||||||