Adverse reactions to Hepatitis C drugs

• Conditions: Hypersensitivity reaction to direct acting antiviral drugs used to treat Hepatitis C; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12618001740280
• Lead Sponsor: Prof Michaela Lucas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-23
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Diagnosis of drug hypersensitivity reaction (HSR) confirmed using:
•Modified European Network of Drug Allergy (ENDA) drug allergy questionnaire.
•Severe Cutaneous Adverse Reactions (SCAR) to drugs criteria.
•Idiosyncratic drug-induced liver injury (iDILI) criteria.
•Clinical severity.
•Direct acting antiviral drug treatment at time of hypersensitivity reaction.
•Laboratory parameters: liver function test, total bilirubin.
•Informed consent for health information acquisition, DNA bio-sample (buccal swab).

Exclusion Criteria

•People under the age of 18years.
•Females that are pregnant.
•Those people not willing to give consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HLA allele as assessed by whole genome sequencing of DNA from buccal swab[At recruitment, after signed consent]

Secondary Outcome Measures

Name	Time	Method
Severity of hypersensitivity reaction as assessed by data-linkage to medical records[Two years after first participant recruited]