A Prospective Observational Descriptive Study and Retrospective Chart Review of Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Sponsor
- Amgen
- Enrollment
- 326
- Primary Endpoint
- Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies for Second-line Treatment.
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies for Third-line Treatment.
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.
The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.
Time Frame: Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).
The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.
Secondary Outcomes
- Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase(12 months (prospective data collection phase))
- Duration of Exposure to ITP Medication(12 months (prospective data collection phase))
- Number of Participants Requiring Splenectomy(12 months)
- Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)(Baseline to month 12 during prospective data collection phase)
- Change From Baseline to Month 12 in Treatment Satisfaction(Baseline to Month 12 during prospective data collection phase)
- Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)(Baseline to Month 12 during prospective data collection phase)