Clinical trial NCT00454857: Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Official title: A Prospective Observational Descriptive Study and Retrospective Chart Review of Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Thrombocytopenic Purpura
Thrombocytopenia
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenic Purpura
Keywords: 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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients s diagnosed with ITP and currently treated for ITP by a hematologist or hematologist-oncologist recruited from community based clinics and adademic/referral centers.

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.

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.

Primary outcomes:
measure: Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies for Second-line Treatment.
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies for Third-line Treatment.
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.
timeFrame: 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).
measure: The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.
timeFrame: 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).
Secondary outcomes:
measure: Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)
timeFrame: Baseline to month 12 during prospective data collection phase
measure: Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
timeFrame: Baseline to Month 12 during prospective data collection phase
measure: Change From Baseline to Month 12 in Treatment Satisfaction
timeFrame: Baseline to Month 12 during prospective data collection phase
measure: Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase
timeFrame: 12 months (prospective data collection phase)
measure: Duration of Exposure to ITP Medication
timeFrame: 12 months (prospective data collection phase)
measure: Number of Participants Requiring Splenectomy
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: