Trials / Completed
CompletedNCT00454857
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
A Prospective Observational Descriptive Study and Retrospective Chart Review of Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 326 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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
- Idiopathic Thrombocytopenic Purpura
- Thrombocytopenia
- Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Thrombocytopenic Purpura
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2008-06-01
- Completion
- 2008-08-01
- First posted
- 2007-04-02
- Last updated
- 2013-11-26
- Results posted
- 2010-05-12
Source: ClinicalTrials.gov record NCT00454857. Inclusion in this directory is not an endorsement.