chronic immune thrombocytopenia chronic immune thrombocytopenia
Conditions
Interventions
None listed
Sponsors
Kudo Kohya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who provide written informed consent before study entry 2. Male and female adult patients 18 years of age or older at the time of enrollment 3. Patients with a documented physician diagnosis of ITP at least 1 year prior to the enrollment 4. Patients who have been prescribed with the same drug(s) for the treatment of ITP for at least 3 months prior to the enrollment; patients with a decrease in the daily dose of medication during the 3 months are considered stable and therefore are eligible 5. Number of platelets count within 3 months prior to the enrollment is available 6. Past medical history is available; at least for 3 months prior to the enrollment at V1
Exclusion criteria
Exclusion criteria: 1. Patients with a documented physician diagnosis of secondary ITP prior to the enrollment 2. Patients diagnosed with Evans syndrome or other forms of thrombocytopenia 3. Patients with history of splenectomy; patients with history of partial splenic embolization are also considered ineligible 4. Patients who have participated in any clinical trial for ITP within 3 months prior to the enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The scores of all the eight domains of SF-36 of Japanese patients with chronic ITP under continuous treatment with any pharmacotherapies for chronic ITP, in comparison to those of healthy Japanese subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The scores from patient-reported outcomes using the following questionnaires of patients with chronic ITP (at V1, the timing of enrollment): a) Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) b) The ITP Life Quality Index (ILQI) c) EuroQoL-5Dimention-5Level (EQ-5D-5L) d) Work Productivity and Activity Impairment (WPAI) e) Patient Health Questionnaire-9 (PHQ-9) f) PRO measurement information system Short Form v1.0 Fatigue-13a (PROMIS SF v1.0 Fatigue-13a) g) Functional Assessment of Cancer Therapy - General item GP5 (FACT-GP5) 2) Past medical history of patients with chronic ITP during the observation period (prior to the enrollment): a) HCRU-related parameters of patients with chronic ITP i. Number of outpatient visits (ITP-related and non-ITP related) ii. Number of operative procedures (ITP-related and non-ITP related) iii. Number of ER visit (ITP-related and non-ITP related) iv. Number of hospitalization (ITP-related and non-ITP related; number and the length of stay [days per one hospitalization]) v. Number of platelet transfusion b) Any pharmacotherapies (for ITP and not for ITP; daily dose and treatment duration of each medication) c) Number of serious bleeding symptoms (ITP-related) d) Blood test value (e.g., platelet count, hemoglobin, white blood count, red blood cell count) e) Duration of ITP since initial diagnosis | — |
Contacts
Public ContactDirect Novartis
Novartis Pharma. K.K.
Outcome results
None listed