Last updated: 11/03/2018 21:38:56
PGx7591: Pharmacogenetic Evaluation of HLA effect on safety events in systemic lupus erythematosus patients treated with GSK2586184 in study JAK115919
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: PGx7591: Pharmacogenetic Evaluation of HLA effect on safety events in systemic lupus erythematosus patients treated with GSK2586184 in study JAK115919
Trial description: GSK2586184 is in development for the treatment of chronic auto-inflammatory diseases. Six subjects receiving GSK2586184 in the study JAK115919 conducted in subjects with systemic lupus erythematosis (SLE) experienced ALT elevations of >3xULN. ALT elevations of >3xULN have not been observed in healthy volunteer or other disease study populations receiving GSK2586184. In the past, genetic associations have been identified between Human Leucocyte Antigen (HLA) alleles and enhanced risk for adverse drug reactions including Drug-Induced Liver Injury (DILI) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Therefore, we tested the hypothesis that HLA alleles may have been associated with the observed liver injury events in JAK115919.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
ALT elevation > 3 x ULN
Timeframe: 16 weeks
Secondary outcomes:
Not applicable
Interventions:
Device: GSK2586184
Enrollment:
1
Observational study model:
Case-Control
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
solcitinib
Collaborators
Not applicable
Study date(s)
March 2014 to April 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
none
- Clinical study subjects included in this analysis were those who:
- provided written informed consent
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical study subjects included in this analysis were those who:
- provided written informed consent
- whose DNA sample was of acceptable quality
- yielded evaluable genotype results
- ALT level information was available
Exclusion criteria:
- N/A
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2014-11-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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