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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00454857 |
This is a multi-center prospective observational descriptive study complemented by a retrospective chart review. Subjects 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, subjects' charts will also be reviewed from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever is less.
Condition | Intervention |
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Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura |
Other: Retrospective Chart Review Other: Patient-reported Outcome Questionnaires Other: Physician Survey |
Study Type: | Observational |
Study Design: | Cohort |
Official Title: | A Prospective Observational Descriptive Study and Retrospective Chart Review of Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
None retained.
Enrollment: | 324 |
Study Start Date: | May 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Subjects with ITP |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Subjects diagnosed with ITP and currently treated for ITP by a hematologist or hematologist-oncologist will be recruited from community based clinics and adademic/referral centers.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050237 |
Study First Received: | March 29, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00454857 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; Canada: Health Canada; Canada: Health Products and Food Branch; EU: CHMP; European Union: European Medicines Agency; France and Sweden: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Italy: Ministry of Health; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board |
Immune Thrombocytopenic Purpura (ITP) Thrombocytopenia Chart Review Platelet Retrospective Prospective |
Non-interventional Health Resource Utilization (HRU) Quality of Life (QOL) Idiopathic Thrombocytopenic Purpura (ITP) Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Observational |
Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Quality of Life Hemostatic Disorders |
Purpura, Thrombocytopenic Thrombocytopathy Signs and Symptoms Thrombocytopenia Hemorrhagic Disorders Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic |
Skin Manifestations Immune System Diseases |