NCT01584765

Rechallenge, Potential Drug Induced Liver Injury (Kaiser)

Rechallenge Analysis: Detection of Potential Drug-Induced Liver Injury Using Kaiser California Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug-induced Liver Injury

Interventions

Type	Name	Description
DRUG	Prescription drugs with known hepatotoxicity	14 prescription drugs with known hepatotoxicity : Amoxicillin/clavulanate, nitrofurantoin, isoniazid, trimethoprim-sulfamethoxazole, duloxetine, valproate, interferon-beta, ciprofloxacin, lamotrigine, phenytoin, diclofenac, terbinafine, levofloxacin, aripiprazole

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-04-25
• Last updated: 2014-07-08