Last updated: 11/07/2018 07:02:59

Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim

GSK study ID
113922
See study documents
Clinicaltrials.gov ID
NCT01439321
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: Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim
Trial description: Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and the risk of severe bleeding complications. The two recently introduced TPO-RA drugs, namely, eltrombopag and romiplostim, have shown efficacious sustained response with continuous administration. Both drugs are indicated for the treatment of thrombocytopia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. While these trials address important clinical questions they were not intended to evaluate what happens in the real-world settings with actual patient living daily lives. The purpose of this health outcomes study is to understand how the two TPO receptor agonists (TPO-RA) currently available in the US are being used in clinical practice and how their use impacts chronic ITP patients’ daily lives. The study hypothesis is that patients who switched to eltrombopag report a better health-related quality of life than those who switched to romiplostim. This study utilized a hybrid design of retrospective chart review study and cross-sectional patient survey. A customized Patient Case Report Form (CRF) will be used to retrospectively collect clinical data from patient medical charts where the primary cohorts consist of patients who have switched from other ITP medication to eltrombopag or romiplostim. A cross-sectional survey will be employed to collect patient reported outcomes (PRO) data, including health-related quality of life and treatment satisfaction, using a compository questionnaire. Analyses of cross-sectional survey data and retrospective medical chart review data in patients who switch to either eltrombopag or romiplostim from their prior primary therapy will be conducted.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

treatment satisfaction scores by domain

Timeframe: During a 5 month period, the questionnaire will be administered to each participant at one time point. The recall period for the TQSM in this study is 3 weeks

Secondary outcomes:

Short-form 36 (SF-36) score

Timeframe: During a 5 month period, the questionnaire will be administered to each participant at one time point. The recall period for the SF-36 in this study is 1 week

Interventions:
  • Biological/vaccine: Eltrombopag
  • Biological/vaccine: Romiplostim
    • Enrollment:
    280
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Kuter DJ, Macahilig C, Grotzinger KM, Poston SA, Weng PF, Dawson KL, Ward M.Treatment patterns and clinical outcomes in patients with chronic immune thrombocytopenia (ITP) switched to eltrombopag or romiplostim.Int J Hematol.2015;101(3):255-263
    Medical condition
    Immune Thrombocytopenic Purpura
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    November 2010 to October 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria
    • Adults 18 years and older diagnosed with chronic ITP
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria
    • Adults 18 years and older diagnosed with chronic ITP
    • Switched to eltrombopag or romiplostim a minimum of 4 weeks prior to index date
    • Received corticosteroids, rituximab, or one TPO-receptor agonist as prior primary therapy before switching to eltrombopag or romiplostim
    • Medical history must be available from chronic ITP diagnosis through to most recent office visit
    • Patients who complete the self-administered questionnaire were the same patients whose medical charts were reviewed Exclusion criteria
    • Age less than 18 years old

    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
    2012-08-10

    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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