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Trial registered on ANZCTR
Registration number
ACTRN12618001740280p
Ethics application status
Submitted, not yet approved
Date submitted
17/10/2018
Date registered
23/10/2018
Date last updated
23/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Adverse reactions to Hepatitis C drugs
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Scientific title
Drug hypersensitivity reactions to direct acting hepatitis C virus antiviral drugs
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Secondary ID [1]
296361
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Nil known
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Universal Trial Number (UTN)
U1111-1222-5058
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypersensitivity reaction to direct acting antiviral drugs used to treat Hepatitis C
310091
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Condition category
Condition code
Inflammatory and Immune System
308836
308836
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0
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Allergies
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Years
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Description of intervention(s) / exposure
The aim of this project is to investigate the underlying genetic mechanism of cases of adverse reactions to direct acting antiviral drugs used to treat Hepatitis C. People on the study will be asked to supply buccal tissue samples (DNA) so that whole genomic analysis will identify potential genetic associations. This may help predict which people are sensitive to these antiviral drugs and therefore prevent severe reactions. Those people with demonstrated hypersensitivity reactions to direct acting antiviral medication will be compared to people treated with direct acting antiviral drugs that have not had a reaction. After the initial recruitment and enrolment visit, there will be no follow up - information obtained will be included in a National drug allergy registry.
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Intervention code [1]
312691
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Early Detection / Screening
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Comparator / control treatment
Those people with demonstrated hypersensitivity reactions to direct acting antiviral medication will be compared to people treated with direct acting antiviral drugs that have not had a reaction.
People identified (by participating hepatologists, clinical immunologists, hospital medical staff) as potentially having HCV treated with direct acting antiviral medications and having a hypersensitivity reaction will be invited to take part in this research study. A similar group of gender and age matched controls (people that have been treated for hepatitis C with direct acting antiviral medications that have not had a hypersensitivity reaction) will be recruited for comparison purposes. The diagnosis of drug hypersensitivity reaction will be verified or dismissed. Those participants that have been treated with direct acting antiviral medications without a verified hypersensitivity reaction will be recruited into the Control group. Recruitment for both groups will be simultaneous and will commence once ethics approval has been granted. Medical records at both Sir Charles Gairdner Hospital (WA) and St Vincent's Hospital (Vic) will be used to identify potential participants.
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Control group
Active
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Outcomes
Primary outcome [1]
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HLA allele as assessed by whole genome sequencing of DNA from buccal swab
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Assessment method [1]
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Timepoint [1]
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At recruitment, after signed consent
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Secondary outcome [1]
353000
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Severity of hypersensitivity reaction as assessed by data-linkage to medical records
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Assessment method [1]
353000
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Timepoint [1]
353000
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Two years after first participant recruited
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• People under the age of 18years.
• Females that are pregnant.
• Those people not willing to give consent.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
SAMPLE SIZE
It is anticipated that 6 patients can be recruited each month, over an 18month period. Therefore, we aim to recruit 108 patients that have an hypersensitivity reaction to a direct acting antiviral medication; each of these patients will have an age and gender matched control patient who did not have a hypersensitivity reaction to a direct acting antiviral medication. We expect this to provide enough information based on similar research to identify genetic differences between the groups.
Statistical analysis
Patient variables, such as age, sex, co-infection history and clinical laboratory parameters (e.g. liver function tests, full blood count, inflammatory markers, biopsy material) will be summarised. Categorical patient variables will be compared between hypersensitivity reaction and control groups using McNemar’s tests, whilst continuous patient variables will be compared between groups using paired t-tests.
The proportion of patients with each HLA allele will be summarised and compared between hypersensitivity reaction and control groups using McNemar’s tests (performed separately for each HLA allele). P-values will be adjusted using the false discovery rate to take into account the multiple comparisons.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/11/2018
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Actual
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Date of last participant enrolment
Anticipated
14/11/2020
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Actual
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Date of last data collection
Anticipated
14/12/2020
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Actual
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Sample size
Target
108
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA,VIC
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [2]
12196
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment postcode(s) [2]
24367
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Centre for HIV and Hepatitis Virology Research
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Address [1]
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176 Hawkesbury Rd, Westmead NSW 2145
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Country [1]
300963
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Australia
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Primary sponsor type
Individual
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Name
Prof Michaela Lucas
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Address
The Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
300541
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Address [1]
300541
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Country [1]
300541
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Other collaborator category [1]
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Individual
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Name [1]
280394
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Prof Alex Thompson
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Address [1]
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St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
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Country [1]
280394
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
301727
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Sir Charles Gairdner Osborne Park Health Care Group Human Research Ethics Committee
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Ethics committee address [1]
301727
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Sir Charles Gairdner Hospital
Level 2, A Block
Hospital Avenue
NEDLANDS WA 6009
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Ethics committee country [1]
301727
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Australia
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Date submitted for ethics approval [1]
301727
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08/08/2018
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Approval date [1]
301727
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Ethics approval number [1]
301727
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Summary
Brief summary
Adverse reactions to direct acting antiviral medications to treat hepatitis C have occurred in some people. These adverse reactions include damage to the liver. The aim of this project is to study the genetic association of these cases of adverse reactions. People that have had direct acting antiviral medications to treat hepatitis C and have had a hypersensitivity reaction will be compared to those that have had direct acting antiviral medications to treat hepatitis C and have not had a hypersensitivity reaction. The study will require people to supply buccal tissue samples so that identification of potential genetic association can be established through DNA testing. This may help predict which people are sensitive to these antiviral drugs and therefore prevent sever reactions. These DNA samples will be destroyed after the genetic testing has been completed.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Michaela Lucas
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Address
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The Harry Perkins Institute of Medical Research
6 Verdun St
Nedlands WA 6008
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Country
87906
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Australia
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Phone
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+61 (08) 6151 0700
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Fax
87906
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Email
87906
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[email protected]
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Contact person for public queries
Name
87907
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Prof Michaela Lucas
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Address
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The Harry Perkins Institute of Medical Research
6 Verdun St
Nedlands WA 6008
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Country
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Australia
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Phone
87907
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+61 (08) 6151 0700
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Fax
87907
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Email
87907
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[email protected]
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Contact person for scientific queries
Name
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Prof Michaela Lucas
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Address
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The Harry Perkins Institute of Medical Research
6 Verdun St
Nedlands WA 6008
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Country
87908
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Australia
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Phone
87908
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+61 (08) 6151 0700
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Fax
87908
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Email
87908
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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