Last updated: 11/03/2018 22:04:51
PGx7611: Genetic Investigation of ALT elevations in Eltrombopag studies in ITP subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: PGx7611: Genetic Investigation of ALT elevations in Eltrombopag studies in ITP subjects
Trial description: The primary and secondary objectives of this study were to evaluate associations between ALT elevations and HLA alleles (HLA-A, -B, -C, -DPB1, -DQA1, -DQB1, and –DRB1 genes) and common genome-wide variants, respectively, in eltrombopag-treated adult and pediatric ITP subjects. Carriage of HLA alleles was tested for association with ALT elevation in a case/control analysis using Fisher’s exact test and by logistic regression, adjusting for GWAS principal components. Linear regression was used to evaluate association between carriage of common HLA alleles and maximum on-treatment ALT (in ULN units), adjusting for GWAS principal components.GWAS genetic markers were tested in an additive genetic model evaluating the number of copies of the non-wild-type allele. Missing genotypes were imputed. For each analysis, the false positive rate was controlled to 5%.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Determine if common HLA alleles or genome-wide genetic variants are associated with elevations in on-treatment ALT levels (>3x ULN) in adult and pediatric ITP subjects treated with eltrombopag.
Timeframe: The day after eltrombopag treatment initiation, and the last day that eltrombopag is received (inclusive)
Secondary outcomes:
Determine if common HLA alleles or genome-wide genetic variants are associated with elevations in on-treatment ALT levels (>5x ULN) or with maximum on-treatment ALT (as a quantitative trait) or with time to first >3x ULN ALT elevation
Timeframe: The day after eltrombopag treatment initiation, and the last day that eltrombopag is received (inclusive)
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Purpura, Thrombocytopaenic, Idiopathic and Hepatitis C
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
September 2014 to October 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
1 - 85 Year
Accepts healthy volunteers
none
- All ITP subjects treated with eltrombopag from 9 clinical trials (TRA100773A, TRA100773B, TRA102537, TRA105325, TRA108057, TRA108062, TRA111433, TRA112940 and TRA115450) that provided written informed consent and a blood sample for PGx research and were successfully genotyped.
- Patients missing on-treatment ALT or with baseline ALT levels ≥ 3x ULN.
Inclusion and exclusion criteria
Inclusion criteria:
- All ITP subjects treated with eltrombopag from 9 clinical trials (TRA100773A, TRA100773B, TRA102537, TRA105325, TRA108057, TRA108062, TRA111433, TRA112940 and TRA115450) that provided written informed consent and a blood sample for PGx research and were successfully genotyped.
Exclusion criteria:
- Patients missing on-treatment ALT or with baseline ALT levels ≥ 3x ULN.
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-24-10
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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