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

NCT00454857 | Completed Results

• 1 other identifier: 20050237
• Study Type: observational
• Target: 326
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic Purpura

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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)

  Baseline to Month 12 during prospective data collection phase

• Change From Baseline to Month 12 in Treatment Satisfaction

  Baseline to Month 12 during prospective data collection phase

• Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase

  12 months (prospective data collection phase)

• Duration of Exposure to ITP Medication

  12 months (prospective data collection phase)

Study Arms (1)

Patients with ITP

Participants with ITP and currently treated for ITP were followed prospectively for a period of 12 months.

Other: Retrospective Chart Review; Other: Patient-reported Outcome Questionnaires; Other: Physician Survey

Interventions

Retrospective Chart Review OTHER

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

Patients with ITP

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).

Patients with ITP

Physician Survey OTHER

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

Patients with ITP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Amgen: lead

Related Links

• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

Biospecimen

Retention: NONE RETAINED

None retained.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Purpura, Thrombocytopenic

Condition Hierarchy (Ancestors)

Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: May 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 26, 2013
• Results First Posted: May 12, 2010

Record last verified: 2013-10