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An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia
Led by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. · Updated on 2026-04-08
36
Participants Needed
9
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 65 years at the time of signing informed consent
- Clinically confirmed chronic primary Immune Thrombocytopenia (ITP) lasting more than 12 months
- No glucocorticoid use for at least 2 weeks before first dose or stable maintenance dose without planned increase within 4 weeks after first dose
- Platelet count below 30 x 10^9/L
- Ability to understand study procedures, willing to sign informed consent, and comply with study protocol
You will not qualify if you...
- Known or suspected allergy to human immunoglobulin, plasma proteins, blood products, or steroid hormones
- Body mass index (BMI) of 30 kg/m2 or higher
- Secondary thrombocytopenia
- Hemoglobin below 90 g/L or immune hemolytic anemia
- Chronic or recurrent neutropenia (absolute neutrophil count below 1.5 x 10^9/L)
- Abnormal liver function (ALT or AST more than 3 times upper limit of normal, or total bilirubin 1.5 times or more upper limit)
- Renal impairment (serum creatinine 1.5 times or more upper limit or creatinine clearance below 60 mL/min)
- Diabetes with HbA1c 7.0% or higher, fasting glucose 7.0 mmol/L or higher, or random glucose 11.1 mmol/L or higher
- Blood diseases with coagulation factor defects
- Selective IgA deficiency with anti-IgA antibodies
- Uncontrolled high or low blood pressure
- Severe cardiovascular or cerebrovascular diseases or other serious systemic diseases unsuitable for enrollment
- Mental illness, epilepsy, cognitive impairment, or incapacity
- Previous nonresponse to immunoglobulin or anti-D immunoglobulin treatment
- Immunoglobulin or anti-D treatment within 4 weeks prior to first dose
- Use of recombinant thrombopoietin receptor agonists within 2 weeks prior to first dose, except stable ineffective treatment
- Immunosuppressive or immunomodulatory drugs within 3 weeks prior to first dose, except stable glucocorticoids or failed stable azathioprine, cyclophosphamide, or danazol treatment
- Rituximab within 8 weeks prior to first dose
- Live attenuated vaccine within 8 weeks prior to first dose or planned during trial
- Planned surgery during trial requiring blood transfusion
- Plans to continue drugs affecting platelet aggregation or coagulation during trial
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV at screening
- Active bacterial or viral infections requiring antibiotics
- Pregnant or breastfeeding women within specified timeframes or planning pregnancy/donation without effective contraception
- History of drug abuse or addiction
- Participation in other drug or device clinical trials within 3 months
- Expected survival less than 3 months or severe concomitant illness
- Poor compliance or unsuitable for trial participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Hacettepe University Faculty of Medicine
Ankara, Altındağ, Turkey (Türkiye), 06230
Actively Recruiting
2
İnönü University Turgut Ozal Medical Center Training and Research Hospital
Malatya, Battalgazi, Turkey (Türkiye), 44280
Actively Recruiting
3
İstanbul University, Istanbul Faculty of Medicine
Istanbul, Fatih, Turkey (Türkiye), 34093
Actively Recruiting
4
Erciyes University Hematology Hospital
Kayseri, Melikgazi, Turkey (Türkiye), 38039
Actively Recruiting
5
VM Medical Park Mersin
Mersin, Mezitli, Turkey (Türkiye), 33200
Actively Recruiting
6
Antalya Training and Research Hospital
Antalya, Muratpaşa, Turkey (Türkiye), 07100
Actively Recruiting
7
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara, Yenimahalle, Turkey (Türkiye), 06200
Actively Recruiting
8
Adana City Education and Research Hospital, Hematology Department
Adana, Yüreğir, Turkey (Türkiye), 01230
Actively Recruiting
9
Gaziantep University Şahinbey Training and Research Hospital
Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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