Clinical Trial: Rechallenge, Potential Drug Induced Liver Injury (Kaiser)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Rechallenge Analysis: Detection of Potential Drug-Induced Liver Injury Using Kaiser California Database
Brief Summary: Drug re-administration or rechallenge should be avoided after drug-induced liver injury (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug and patient subjects. In order to better predict these outcomes, the objective of this analysis is to assess clinical outcomes of positive drug rechallenge following possible drug-induced liver injury. Electronic medical records from Kaiser Permanente California (KPSC), a managed care organization, will be utilized to identify patients who experience possible drug-induced liver injury following exposure to medications associated with hepatotoxicity, and who are then rechallenged with the medication.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Liver injury rechallenge [ Time Frame: Up to seven and a half years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Severe positive rechallenge [ Time Frame: Up to seven and a half years ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: April 12, 2012
Date Started: February 2012
Date Completion:
Last Updated: July 3, 2014
Last Verified: July 2014