Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

October 23, 2013 updated by: Amgen

A Prospective Observational Descriptive Study and Retrospective Chart Review of Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with ITP
Participants with ITP and currently treated for ITP were followed prospectively for a period of 12 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)
Time Frame: Baseline to month 12 during prospective data collection phase
The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best).
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)
Time Frame: Baseline to Month 12 during prospective data collection phase
The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0).
Baseline to Month 12 during prospective data collection phase
Change From Baseline to Month 12 in Treatment Satisfaction
Time Frame: Baseline to Month 12 during prospective data collection phase
Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.
Baseline to Month 12 during prospective data collection phase
Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase
Time Frame: 12 months (prospective data collection phase)
The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.
12 months (prospective data collection phase)
Duration of Exposure to ITP Medication
Time Frame: 12 months (prospective data collection phase)
Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.
12 months (prospective data collection phase)
Number of Participants Requiring Splenectomy
Time Frame: 12 months
The number of participants who required a splenectomy during the 12-month prospective phase of the study.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (Estimate)

April 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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