Retrospective & Prospective Observational Study of Subjects With ITP - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00454857

Purpose

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
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)

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

The relative utilization rates of ITP therapies from the date of enrollment to the end of the prospective data collection period. [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the impact of the use of ITP therapies on health-related quality of life and treatment satisfaction in subjects. [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: No ]
Measure the level of health resource utilization and costs associated with the use of ITP therapies and with their side effects. [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: No ]
Describe the response rates, duration of response, and side effects associated with ITP therapies. [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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.

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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.

Criteria

Inclusion Criteria:

Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
Subject is equal to or greater than 18 years of age.
Subject 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:

Subject participated in clinical trial(s) during the past 36 months.
Subject is considering participation in a clinical trial within the next 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454857

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

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 History of Changes
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

Keywords provided by Amgen:

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Purpura
Signs and Symptoms
Skin Manifestations
Autoimmune Diseases
Hemorrhagic Disorders
Thrombocytopenia

Immune System Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic

ClinicalTrials.gov processed this record on September 10, 2009