Protocol Summary for 113918
| Protocol Id: | 113918 |
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| Title: | Cost Analysis of Thrombocytopenia Treatment in Patients with Chronic Immune (Idiopathic) Thrombocytopenic Purpura |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Observational |
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| Brief Summary: | 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. |
| Detailed Description: | |
| Record Verification Date: | |
| Status: | Terminated |
| Why Study Stopped: | Insufficient number of patient records met inclusion criteria |
| Study Start Date: | November 2010 |
| Study Completion Date: | July 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | July 2011 |
| Primary Completion Date Type: | Actual |
| Study Design: | Cohort |
| Time Perspective: | Retrospective |
| Biospecimen Retention: | None retained |
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| Study Population: | This study will include patient records from adult commercial health insurance and Medicare Advantage members with a chronic Immune (idiopathic) thrombocytopenic purpura (ITP) diagnosis. |
| Sampling Method: | Non probability |
| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria
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| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | |
| Enrollment: | 772 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria