Retrospective & Prospective Observational Study of Patients with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Study Details
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.
Protocol Summary
The number of subjects utilizing Immune (idiopathic) Thrombocytopenic Purpura (ITP) therapies from the date of enrollment to the end of the prospective data collection period: First-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Second-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Third-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Fourth-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Fifth-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Sixth-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Seventh or greater-line treatment.
Timeframe: Study duration is 12 months
The number of subjects utilizing ITP therapies from the date of enrollment to the end of the prospective data collection period: Treatments with unknown starting date.
Timeframe: Study duration is 12 months
Changes in subject reported quality of life from baseline to month 12 measured by the ITP-Patient Assessment Questionnaire (PAQ), Treatment Satisfaction Questionnaire for Medication (TSQM) and European Quality of Life-5 Dimensions (EQ5D)
Timeframe: Change from baseline to month 12 during prospective data collection period
Number of subjects receiving drug therapies for the treatment of ITP during the prospective phase of the study.
Timeframe: Study duration is 12 months
Duration of exposure.
Timeframe: Study duration is 12 months
Subjects requiring splenectomy.
Timeframe: 12 months