Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immune Thrombocytopenic Purpura
Intervention: Eltrombopag (Biological); Romiplostim (Biological)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: treatment satisfaction scores by domain
Secondary outcome: Short-form 36 (SF-36) score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 2010
Last updated: June 21, 2012
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