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

NCT07233213 | Recruiting Phase 3

• 1 other identifier: GLS-IVIG-A01-III
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 9

Brief 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)

Keywords

autoimmune hemorrhagic disease; hemorrhage

Outcome Measures

Primary Outcomes (1)

• Improved platelet response within 7 days of the first transfusion

  The response rate is defined as the proportion of patients whose platelet count \> 30 × 109/L and increased to more than 2 times of baseline within 7 days after the first IVIg transfusion and absence of bleeding.

  Within 7 days of the first transfusion

Secondary Outcomes (7)

• Time to and duration (days) of platelet count > 30 × 109/L

  Within 7 days after the first IVIg infusion

• Peak and time to peak platelet count

  After the first infusion of IVIg

• Number and percentage of patients achieving complete response (CR), response (R), non-response (NR) and relapse

  Within 28 days after the first infusion

• Time to arrival of CR or R response and duration of response

  Within 28 days after the first infusion

• Effective rate

  On the 14th, 21st and 28th day after the first dose

Study Arms (1)

Patients who meet all of the following criteria are eligible to be included in this clinical trial.

EXPERIMENTAL

Investigational Product Name: Human immunoglobulin (pH4) for intravenous injection Formulation: Injection Specification: 5 g/vial (5%, 100 mL) Manufacturer: Grand Shuyang Life Sciences (Chengdu) Co., Ltd. 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). Dosage: 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.

Drug: Human immunoglobulin (pH4) for intravenous injection

Interventions

Human immunoglobulin (pH4) for intravenous injection DRUG

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.

Patients who meet all of the following criteria are eligible to be included in this clinical trial.

Eligibility Criteria

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

You may qualify if:

• At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;
• Patients with clinically confirmed chronic ITP (i.e., the course of disease \> 12 months from diagnosis to signing the informed consent form);
• Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2 weeks before the first dose, and did not plan to increase the dosage of glucocorticoids or add other platelet-elevating drugs within 4 weeks after the first dose;
• Platelet count \< 30 × 109/L;
• Patients who understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict accordance with the clinical study protocol.

You may not qualify if:

• Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and/or blood products, as well as excipients of the investigational drug, including those with a history of steroid hormone allergy;
• BMI ≥ 30 kg/m2;
• Secondary thrombocytopenia;
• Patients with the following clinical manifestations or disease history at screening:
• Hemoglobin \<90 g/L or combined with immune hemolytic anemia;
• Chronic or recurrent neutropenia (defined as absolute neutrophil count \< 1.5 × 109/L);
• Patients with abnormal liver function: defined as ALT and/or AST \> 3 times of the upper limit of normal; and/or total bilirubin ≥ 1.5 times of the upper limit of normal;
• Patients with related diseases of renal impairment, or serum creatinine ≥ 1.5 times the upper limit of normal value or creatinine clearance \< 60 mL/min; ⑤. Patients with dysglycemia, including: Confirmed diagnosis of type 1/2 diabetes mellitus with HbA1c ≥7.0%, Fasting glucose ≥7.0 mmol/L (126 mg/dL), or Random glucose ≥11.1 mmol/L (200 mg/dL);
• ⑥. Blood diseases with coagulation factor defects;
• ⑦. Selective IgA deficiency patients with anti-IgA antibodies;
• ⑧. Patients with uncontrollable hypertension (SBP\>160 mmHg or DBP\>100 mmHg) or hypotension (SBP\<90 mmHg or DBP\<60 mmHg);
• ⑨. Patients with hyperviscosity, severe cardiovascular and cerebrovascular diseases (such as TIA, stroke, thrombotic disease, congestive heart failure of NYHA classification III/IV, arrhythmia requiring drug therapy (unstable angina pectoris) or myocardial infarction, etc.) and other serious systemic diseases before signing the informed consent form, who are not suitable for enrollment as judged by the investigator;
• ⑩. Suffering from mental illness, obvious mental disorder or epilepsy; incapacitated or cognitively impaired;
• Patients who failed to respond to previous treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin;
• Patients who had received treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin within 4 weeks prior to the first dose, or any other treatment with blood, blood products or blood derivatives within 4 weeks before signing the informed consent form;

Sponsors & Collaborators

• Grand Shuyang Life Sciences (Chengdu) Co., Ltd.: lead

Study Sites (9)

Hacettepe University Faculty of Medicine

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

İnönü University Turgut Ozal Medical Center Training and Research Hospital

Malatya, Battalgazi, 44280, Turkey (Türkiye)

RECRUITING

İstanbul University, Istanbul Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Erciyes University Hematology Hospital

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

RECRUITING

VM Medical Park Mersin

Mersin, Mezitli, 33200, Turkey (Türkiye)

RECRUITING

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07100, Turkey (Türkiye)

RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

Adana City Education and Research Hospital, Hematology Department

Adana, Yüreğir, 01230, Turkey (Türkiye)

RECRUITING

Gaziantep University Şahinbey Training and Research Hospital

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Hemorrhage

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, open-label, multicenter phase III clinical trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

TU (9)