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RECRUITING

NCT06962631

PHASE3

V-IMMUNE® for Immune Thrombocytopenia

Sponsor: On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.

View on ClinicalTrials.gov

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.

Official title: V-IMMUNE® for Immune Thrombocytopenia: A Prospective Multicenter Study to Evaluate the Efficacy and Safety of Human Immunoglobulin in Adult and Pediatric Participants With Immune Thrombocytopenia. TIP Study

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-18

Completion Date

2027-02-27

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Immune Thrombocytopenia (ITP)

Interventions

BIOLOGICAL

5% (5g/100 ml) intravenous immunoglobin

A 5% human normal immunoglobulin I.P. (5 g/100 mL) V-IMMUNE® will be administered at a dose of 1 g/kg, intravenously, once daily for 2 consecutive days (Day 1 and Day 2). The infusion rate starts at 0.01 mL/kg/min during the first 30 minutes and is gradually increased up to 0.06 mL/kg/min if no adverse events occur. This will constitute the first cycle of V-IMMUNE® treatment. The dose of 1 g/kg/day on 2 consecutive days is consistent with recommendations for the use of other IVIG products in Immune Thrombocytopenia. If the platelet count is not maintained for the desired duration after the first V-IMMUNE® cycle, and at the discretion of the investigator and the patient/legal representative, participants may receive up to one additional cycle of V-IMMUNE®-at the same dosing regimen used in Cycle 1-between Day 15 and Day 30 Pre-medication before infusion : IV rapidly infusion of 0.9% normal saline 500 mL, or 10 ml/kg pediatrics and diphenhydramine 50 mg IV or 1.25 mg/kg IV (pediatrics)

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

Locations (2)

IMIP Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Santa Casa de Misericórida de São Paulo

São Paulo, São Paulo, Brazil