Last updated: 11/03/2018 15:50:00
Cost Analysis of Thrombocytopenia Treatment in Patients with Chronic Immune (Idiopathic) Thrombocytopenic Purpura
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Discontinued
Discontinued
Trial overview
Official title: Cost Analysis of Thrombocytopenia Treatment in Patients with Chronic Immune (Idiopathic) Thrombocytopenic Purpura
Trial description: This is a retrospective claims database study to evaluate outcomes associated with the management of chronic Immune (idiopathic) thrombocytopenic purpura (ITP). The objectives are to describe real-world treatment patterns and evaluate healthcare utilization and costs for the management of ITP by treatment type. This study is a descriptive assessment and does not attempt to address any specific hypotheses. All study variables, including baseline and outcome measures, will be analyzed descriptively. Using medical/pharmacy claims and enrollment data of a large United States (US) managed care plan, adult patients being treated for chronic ITP (International Classification of Disease, 9th Revision, Clinical Modification [ICD-9] code 287.31) will be identified. The study will evaluate patient records from August 2008 to June 2010. Patients will be stratified into cohorts based on the treatments prescribed for chronic ITP. Patients treated with chemotherapy will be excluded, as will those with hepatitis, HIV or heparin-induced thrombocytopenia. Sequence and rates of ITP treatments and splenectomy will be assessed. Study subjects will be commercial health plan and Medicare Advantage enrollees. The primary outcomes will include healthcare utilization and costs.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Treament costs
Timeframe: A continuous enrollment period during the 23-month patient-record review
Secondary outcomes:
Not applicable
Interventions:
Vaccine: IVIG
Vaccine: Rituximab
Vaccine: Romiplostim
Vaccine: Eltrombopag
Vaccine: Anti-D
Procedure: Splenectomy
Drug: Corticosteroids
Enrollment:
772
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Thrombocytopaenia
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
November 2010 to September 2011
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Inclusion Criteria
- at least 2 claims with a diagnosis of ITP in any position (ICD-9 = 287.31) at least 5 days apart within the identification period or at least 1 claim for eltrombopag or romiplostim (the earliest date of ITP diagnosis or of eltrombopag or romiplostim receipt will be considered the diagnosis index date)
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- at least 2 claims with a diagnosis of ITP in any position (ICD-9 = 287.31) at least 5 days apart within the identification period or at least 1 claim for eltrombopag or romiplostim (the earliest date of ITP diagnosis or of eltrombopag or romiplostim receipt will be considered the diagnosis index date)
- at least one diagnostic claim with evidence of receipt of treatment for ITP including a pharmacy claim for corticosteroids, intervenous immunoglobulin (IVIG), Rho(D) immune globulin, eltrombopag, romiplostim, rituximab, or other ITP medication or a procedure code for a splenectomy
- commercial or Medicare Advantage health plan enrollees 18 years of age or older
- continuous enrollment with medical and pharmacy coverage for at least 182 days prior to the index date (baseline period) and a minimum of 90 days after the index date (follow-up period); Exclusion Criteria
- diagnoses for hepatitis, HIV, or heparin-induced ITP at any time during the baseline or follow-up period
- evidence of use of chemotherapy at any time during the baseline or follow-up period
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
Discontinued
Actual primary completion date
Not applicable
Actual study completion date
2011-07-09
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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