NCT07233213

An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia

An Open-label, Single-arm, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Human Immunoglobulin for Intravenous Injection (5%) in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Grand Shuyang Life Sciences (Chengdu) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Human immunoglobulin (pH4) for intravenous injection	Administration: Direct intravenous drip at the initial rate of 1.0 ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, it can be gradually increased. The fastest drip rate should not exceed 3.0 ml/min (about 60 drops/min). Direct intravenous drip, 0.4 g/kg daily for 5 consecutive days. The body weight value is kept as an integer (rounded off), and the dose calculated by body weight is within the allowable range of the theoretical dose ± 5 ml. For example, if the body weight of a patient is 57 kg and the theoretical dosage is 22.8 g/day based on 0.4 g/kg per day of human immunoglobulin for intravenous injection (5%, 5g/100ml strength), 456 ml of drug will be required, so the actual dose ranging from 451 ml to 461 ml is allowable.

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-11-18
• Last updated: 2026-04-08

Locations

9 sites across 1 country: Turkey (Türkiye)