Last updated: 11/03/2018 15:50:00

Cost Analysis of Thrombocytopenia Treatment in Patients with Chronic Immune (Idiopathic) Thrombocytopenic Purpura

GSK study ID
113918
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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)

    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
    Other
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website