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

NCT00454857 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 326

Last updated 2013-11-26

Study results available
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Summary

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.

Conditions

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

Interventions

OTHER

Retrospective Chart Review

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

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).

OTHER

Physician Survey

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-06-30
Completion
2008-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454857 on ClinicalTrials.gov