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Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

NCT ID: NCT00454857

Last Updated: 2013-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-08-31

Brief Summary

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This is a multi-center prospective observational descriptive study complemented by a retrospective chart review. Patients diagnosed with ITP and currently treated for ITP by a hematologist or hematologist-oncologist will be recruited from community-based clinics and academic/referral centers. They will be followed prospectively for a period of 12 months. At inception, participants' charts will also be reviewed from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever is less.

Detailed Description

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Time Perspective: 12 months prospective chart review study with a retrospective chart review for a period up to 36 months from the start of the study, since the date of diagnosis for ITP.

Conditions

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Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura

Keywords

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Thrombocytopenia Chart Review Platelet Retrospective Prospective Non-interventional Health Resource Utilization (HRU) Quality of Life (QOL) Immune Thrombocytopenic Purpura (ITP) Idiopathic Thrombocytopenic Purpura (ITP) Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Observational

Study Design

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Observational Model Type

COHORT

Study Groups

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Patients with ITP

Participants with ITP and currently treated for ITP were followed prospectively for a period of 12 months.

Retrospective Chart Review

Intervention Type OTHER

Retrospective chart review for up to 36 months of enrollment date.

Patient-reported Outcome Questionnaires

Intervention Type OTHER

Quality of lige questionnaires as well as treatment satisfaction questionnaires are required monthly. Includes QOL, ITP-PAQ (immune thrombocytopenic purpura - patient assessment questionnaire), EQ-5D, and TSQM (Treatment Satisfaction Questionnaire for Medication).

Physician Survey

Intervention Type OTHER

Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.

Interventions

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Retrospective Chart Review

Retrospective chart review for up to 36 months of enrollment date.

Intervention Type OTHER

Patient-reported Outcome Questionnaires

Quality of lige questionnaires as well as treatment satisfaction questionnaires are required monthly. Includes QOL, ITP-PAQ (immune thrombocytopenic purpura - patient assessment questionnaire), EQ-5D, and TSQM (Treatment Satisfaction Questionnaire for Medication).

Intervention Type OTHER

Physician Survey

Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
* Is equal to or greater than 18 years of age.
* Is willing and able to complete a series of questionnaires.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria

* Participated in clinical trial(s) during the past 36 months.
* Is considering participation in a clinical trial within the next 12 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Australia France Germany Italy Spain United Kingdom United States

Related Links

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http://www.nplate.com/

FDA-approved Drug Labeling

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20050237

Identifier Type: -

Identifier Source: org_study_id