N/A
N=326
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Idiopathic Thrombocytopenic Purpura · Thrombocytopenia · Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) · Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT00454857 ↗Enrolled (actual)
326
Serious AEs
—
Results posted
May 2010
Primary outcome: Primary: Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment — 128; 37; 3; 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Retrospective Chart Review (Other); Patient-reported Outcome Questionnaires (Other); Physician Survey (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment |
128; 37; 3; 11; 74; 36 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies for Second-line Treatment. |
98; 54; 16; 16; 0; 48 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies for Third-line Treatment. |
47; 50; 15; 14; 0; 50 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment. |
26; 28; 14; 14; 0; 56 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment |
13; 28; 10; 11; 0; 41 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment. |
16; 25; 7; 8; 0; 34 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment. |
30; 33; 19; 11; 0; 41 | — |
| PRIMARY The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date. |
25; 4; 0; 0; 4; 17 | — |
| SECONDARY Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ) |
6.7; 7.2; 9.4; 9; 6.4; 4 | — |
| SECONDARY Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) |
4.1 | — |
| SECONDARY Change From Baseline to Month 12 in Treatment Satisfaction |
1.8; 2.8; 7.9; 0.3 | — |
| SECONDARY Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase |
14; 14; 7; 49; 4; 19 | — |
| SECONDARY Duration of Exposure to ITP Medication |
2.0; 7.3; 0.2; 3.6; 1.5; 7.5 | — |
| SECONDARY Number of Participants Requiring Splenectomy |
15 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00454857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.