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Evaluation of health-related quality of life impairment and associated factors in Japanese patients with chronic immune thrombocytopenia using patient-reported outcomes (EQUITY-J (Evaluating the QUality of life of patients with chronic Immune ThrombocYtopenia in Japan))

Evaluation of health-related quality of life impairment and associated factors in Japanese patients with chronic immune thrombocytopenia using patient-reported outcomes (EQUITY-J (Evaluating the QUality of life of patients with chronic Immune ThrombocYtopenia in Japan))

Kudo Kohya

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

kohya.kudo@novartis.com

Novartis Direct

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

kohya.kudo@novartis.com

Not Recruiting

Mar. 01, 2025

Observational

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

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

Both

chronic immune thrombocytopenia

chronic immune thrombocytopenia

D016553

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.

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

+81-3-6416-1868

Jan. 16, 2025

No

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