Health TrialsbyHealthPanel

V-IMMUNE® for Immune Thrombocytopenia

ConditionImmune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorOn Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Non-immune thrombocytopenia

Active sepsis

Pregnancy (pregnant or breastfeeding)

History of hypersensitivity reaction to blood or blood products, IVIG, or any other IgG preparation

Trial design

Design model

Single group

Treatments tested in this trial

  • 5% (5g/100 ml) intravenous immunoglobin

    Biological/Vaccine

    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)

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients achieving a platelet count ≥50,000/mm³ on or before Day 9 following the first infusion

Evaluate the efficacy of V-IMMUNE® in raising the platelet count of individuals with immune thrombocytopenia to a threshold of 50,000/mm³ or greater by or before Day 9 following the first dose. The proportion will be the ratio between the number of patients who achieved platelet count ≥ 50,000/mm3 / total of patients who received at least one dose of V-Immune® and had laboratory assessments performed at least once during the scheduled visits within 9 days.

Time frame
9 days

Secondary outcomes

1

Therapeutic response defined as the increase in platelets count

Proportion of individuals with immune thrombocytopenia who achieve a complete or partial therapeutic response by or before Day 9 following the first dose of V-IMMUNE®. Response criteria can be: 1. Complete response (remission): platelet count ≥100,000/mm³ with no clinically significant bleeding; 2. Partial response (remission): platelet count between 30,000-100,000/mm³ or at least double the baseline count, with no clinically significant bleeding.

Time frame
9 days
2

Bleeding occurrence classified according to CTCAE version 5.0

Number of bleeding events (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0; up to Day 30 after the first infusion.

Time frame
30 days
3

Number of days with platelets count ≥ 50,000/mm3

Duration (in days) during which the platelet count remains ≥50,000/mm³ following the first treatment cycle with V-IMMUNE®.

Time frame
90 days
4

Proportion of infusions during which one or more adverse events (AEs) occurred

Proportion of infusions during which one or more adverse events (AEs) occurred within a predefined temporal window post-infusion

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.

Lead sponsor

Hospital do Coracao

Collaborator

Source ClinicalTrials.gov
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