Idiopathic Thrombocytopenic PurpuraNCT00454857

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

An observational study of Idiopathic Thrombocytopenic Purpura and Thrombocytopenia, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
What is being tested?: Retrospective Chart Review, Patient-reported Outcome Questionnaires and Physician Survey
How many people: 326 participants
Where: No sites listed yet
Study dates: May 2006to Aug 2008
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

Participated in clinical trial(s) during the past 36 months.
Is considering participation in a clinical trial within the next 12 months.

About this study

Official title: 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.

Read the 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.

Conditions: Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenic Purpura
Being tested: Retrospective Chart Review, Patient-reported Outcome Questionnaires, Physician Survey
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
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia, Purpura, Thrombocytopenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Retrospective Chart ReviewOther
Retrospective chart review for up to 36 months of enrollment date.
Patient-reported Outcome QuestionnairesOther
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).
Physician SurveyOther
Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.

Study groups in NCT00454857
Study group	Role	What they receive
Patients with ITP		Participants with ITP and currently treated for ITP were followed prospectively for a period of 12 months. Receives: Other: Retrospective Chart Review; Other: Patient-reported Outcome Questionnaires; Other: Physician Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment
The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.
Measured: 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.
The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.
Measured: 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.
The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.
Measured: 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.
The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.
Measured: 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
The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.
Measured: 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.
Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.
Measured: 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.
The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.
Measured: 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.
The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.
Measured: 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 (6)

Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)
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).
Measured: 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)
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).
Measured: Baseline to Month 12 during prospective data collection phase
Change From Baseline to Month 12 in Treatment Satisfaction
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.
Measured: Baseline to Month 12 during prospective data collection phase
Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective 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.
Measured: 12 months (prospective data collection phase)
Duration of Exposure to ITP Medication
Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.
Measured: 12 months (prospective data collection phase)
Number of Participants Requiring Splenectomy
The number of participants who required a splenectomy during the 12-month prospective phase of the study.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Aug 2008

First posted2 Apr 2007 (estimated)
Study startMay 2006
Primary completionJun 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00454857
Sponsor's protocol ID: 20050237
Status last verified: Oct 2013
First submitted: 29 Mar 2007
Last updated: 26 Nov 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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