Last updated: 11/03/2018 17:22:15
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)
Trial description: To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy.<Priority investigation item>Thromboembolism
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of subjects with any adverse events treated with REVOLADE
Timeframe: 1 year
Secondary outcomes:
Appearance of thromboembolism
Timeframe: 1 year
Interventions:
Drug: Eltrombopag
Enrollment:
1000
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Purpura, Thrombocytopaenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
December 2010 to October 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Subjects with chronic idiopathic thrombocytopenic purpura
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with chronic idiopathic thrombocytopenic purpura
Exclusion criteria:
- Not applicable
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
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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