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Completed

NCT Number: NCT00454857

Retrospective & Prospective Observational Study of Patients 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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrospective Chart Review

Other

Retrospective chart review for up to 36 months of enrollment date.

Patient-reported Outcome Questionnaires

Other

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 Survey

Other

Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 2, 2007
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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