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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01439321
First received: September 21, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Immune Thrombocytopenic Purpura
Biological: Eltrombopag
Biological: Romiplostim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • treatment satisfaction scores by domain [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Short-form 36 (SF-36) score [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The SF-36 is a general overall health instrument consisting of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Scales include general health, limitations of activities, physical functioning, emotional health, social activities, pain, and energy/ emotional functioning. Scores for social functioning and physicial functioning will also be reported


Enrollment: 280
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Switched to Eltrombopag
Other Name: Promacta® is a registered trademark of GlaxoSmithKline
Biological: Romiplostim
Switched to Romiplostim
Other Name: Nplate® is a registered trademark of Amgen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439321

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01439321     History of Changes
Other Study ID Numbers: 113922
Study First Received: September 21, 2011
Last Updated: June 21, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
treatment satisfaction
romiplostim
eltrombopag
chronic immune thrombocytopenic pupura

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on October 19, 2014