NCT06962631 V-IMMUNE® for Immune Thrombocytopenia

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 31 participants in total. It began in 2025-07-18 with a primary completion date of 2026-08-27.

Brief Summary

This is a multicenter, prospective clinical trial evaluating the efficacy and safety of V-IMMUNE®, a 5% human normal immunoglobulin formulation administered intravenously, for the treatment of immune thrombocytopenia (ITP) in patients aged ≥1 year. The primary objective is to assess the proportion of patients achieving a platelet count ≥50,000/mm³ on or before Day 9 following the first infusion. The trial employs a single-group design, comparing outcomes to historical controls derived from the literature. Eligible patients must have a confirmed diagnosis of ITP with a platelet count ≤20,000/mm³ and no concurrent conditions likely to cause thrombocytopenia. Key exclusions include non-immune thrombocytopenia, active sepsis, pregnancy or lactation, hypersensitivity to blood products or IgG preparations, and various significant comorbidities (e.g., uncontrolled hypertension, severe hepatic or renal impairment, recent rituximab use). The intervention consists of V-IMMUNE® at a dose of 1 g/kg, administered once daily for two consecutive days, with infusion rates titrated from 0.01 mL/kg/min to 0.06 mL/kg/min. Standard pre-medication protocols (IV normal saline and diphenhydramine) are administered to mitigate infusion-related reactions and reduce the risk of thromboembolic events. Patients will be monitored at multiple time points from baseline through Day 90, with primary efficacy evaluation at Day 9. Secondary endpoints include duration of platelet response, overall treatment response rate, bleeding events, and incidence of infusion-related adverse events.

Eligibility Criteria

Inclusion Criteria: * Age ≥1 year; * Confirmed diagnosis of immune thrombocytopenia ( newly diagnosed, persistent or chronic); * Platelet count ≤20,000/mm³ at the time of enrollment; * No other conditions that, in the investigator's opinion, could cause thrombocytopenia; * Agreement to use effective contraceptive practices/methods throughout the entire study participation by female patients of childbearing potential and able to become pregnant, unless there is a documented medical contraindication. Exclusion Criteria: * Non-immune thrombocytopenia * Active sepsis * Pregnancy (pregnant or breastfeeding) * History of hypersensitivity reaction to blood or blood products, IVIG, or any other IgG preparation * Intolerance to any component of V-IMMUNE® * Previous diagnosis of IgA deficiency, history of reactions to products containing IgA, or history of anti-IgA antibodies * Participation in any other study involving an investigational product * Known HIV, HCV, or HBV infection * AST (TGO) and/or ALT (TGP) \>2.5× the upper limit of normal or 2.5 times baseline values * Serum creatinine \>2× the upper limit of normal or 2 times baseline values * BUN \>2.5× the upper limit of normal or 2.5 times baseline values * History of NYHA class III or IV heart failure * Uncontrolled hypertension with systolic BP \>180 mmHg or diastolic BP \>100 mmHg * A history of hyperviscosity states, transient ischemic attack (TIA), stroke, other thromboembolic events, or acute coronary syndrome (ACS) * Neoplasia under active treatment * Child-Pugh class B or C liver failure * Alcohol, opioid, or psychotropic substance abuse within the past 12 months * Receipt of rituximab within 6 months prior to Day 1 * Acute or chronic conditions (e.g., but not limited to, renal disease or diseases predisposing to renal impairment, coronary artery disease, or protein-losing enteropathy) that, in the investigator's opinion, may interfere with the conduct of the study An acquired health condition such as chronic lymphocytic leukemia, multiple myeloma, or chronic or recurrent neutropenia (absolute neutrophil count \<1,000/mm³) History of hemolytic anemia Receipt of any IV immunoglobin preparation within 1 month prior to Day 1 Use of corticosteroids, cyclophosphamide, azathioprine, or attenuated androgens with a planned dose increase before Day 10 following IV immunoglobin infusion

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