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

GSK study ID
201490
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Control
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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