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

NCT01439321 | Completed

• 1 other identifier: 113922
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Immune Thrombocytopenic Purpura

Keywords

treatment satisfaction; romiplostim; eltrombopag; chronic immune thrombocytopenic pupura

Outcome Measures

Primary Outcomes (1)

• treatment satisfaction scores by domain

  Treatment satisfaction will be captured with the Treatment Satisfaction Questionnaire for Medication (TSQM). The questionnaire is composed of 14 items. Mean scores will be reported for each treatment group by domain. The domains of the TSQM are effectiveness, side effects, convenience, and global satisfaction

  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 (1)

• Short-form 36 (SF-36) score

  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

Study Arms (1)

Patient with Chronic Immune Thrombocytopenic Purpura

Patients with chronic ITP who switch from their previous treatment of corticosteroids, rituximab, or eltrombopag or romiplostim to eltrombopag or romiplostim and have been on the new treatment for at least four weeks

Biological: Eltrombopag; Biological: Romiplostim

Interventions

Eltrombopag BIOLOGICAL

Switched to Eltrombopag

Also known as: Promacta® is a registered trademark of GlaxoSmithKline

Patient with Chronic Immune Thrombocytopenic Purpura

Romiplostim BIOLOGICAL

Switched to Romiplostim

Also known as: Nplate® is a registered trademark of Amgen

Patient with Chronic Immune Thrombocytopenic Purpura

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will include adult patients with a diagnosis of immune (idiopathic) thrombocytopenic purpura (ITP) who switched to eltrombopag or romiplostim.

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years old

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag; romiplostim

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 25, 2012

Record last verified: 2012-06