AN OPEN-LABEL STUDY OF INTRAVENOUS IMMUNOGLOBULIN (5%) FOR THE TREATMENT OF PRIMARY IMMUNE THROMBOCYTOPENIA
Status:
RECRUITING
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG). This clinical study is conducted to evaluate the efficacy and safety of 5% IVIG in patients with primary Immune Thrombocytopenia (ITP).
The study includes 4 periods and 9 visits (designated as V):
* Screening period (V1: 14 days before the first administration, preliminary examination);
* Baseline Period (V2: within 24 h before the first dose, Day 0);
* Treatment Period (V3: Day 1 to Day 5, administration of the drug in a hospital setting);
* Follow-up Period (V4-V9: visits to Study Site on Day 6, Day 7, Day 14 + 2, Day 21 + 3, Day 28 + 4, and Day 90 (+ 14) after the first dose).
In this study, the investigational product 5% IVIG will be administered at a dose of 0.4 g/kg/day (direct intravenous drip) for 5 consecutive days. The total duration of your participation in the study will be approximately 104 days. The investigational product will only be provided during the study period. It will not be supplied after the study ends.
The study will be conducted at clinical centers in Turkey. It is planned to obtain data from 36 patients included in the study (no more than 48 screened patients).