V-IMMUNE® for Immune Thrombocytopenia

NCT06962631 | Recruiting Phase 3 DMC

• 1 other identifier: TIP study
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Immune Thrombocytopenia (ITP)

Keywords

phase III; clinical trial; immune thrombocytopenia; human immunoglobulin; platelets

Outcome Measures

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.

  9 days

Secondary Outcomes (7)

• Therapeutic response defined as the increase in platelets count

  9 days

• Bleeding occurrence classified according to CTCAE version 5.0

  30 days

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

  90 days

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

  72 hours

• Total number of adverse events infusion related during the whole study

  30 days

Study Arms (1)

Intervention arm

EXPERIMENTAL

Intervention arm will receive a human normal immunoglobulin to be administered intravenously, once daily for 2 consecutive days (Day 1 and Day 2). If the platelet count is not maintained for the desired duration after the first immunoglobin infusion, and at the discretion of the investigator and the patient/legal representative, participants may receive up to one additional cycle between Day 15 and Day 30 Pre-Medication Rapid IV infusion of 500 mL of 0.9% saline, 50 mg of diphenhydramine IV followed by saline 0.9% slow infusion Pediatrics, before the infusion of PSI, an IV infusion of 0.9% sodium chloride (normal saline) at 10 mL/kg over 1 hour, up to a maximum volume of 500 mL, will be administered, along with diphenhydramine 1.25 mg/kg IV, up to a maximum dose of 50 mg. At the end of the V IMMUNE® infusion, administer 0.9% sodium chloride IV at 10 mL/kg, up to a maximum of 500 mL, at an infusion rate of 10 mL/kg, to maintain a patent venous access for at least 30 to 40 minutes.

Biological: 5% (5g/100 ml) intravenous immunoglobin

Interventions

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

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)

Also known as: V-IMMUNE

Intervention arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.: lead
• Hospital do Coracao: collaborator

Study Sites (2)

IMIP Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-902, Brazil

NOT YET RECRUITING

Santa Casa de Misericórida de São Paulo

São Paulo, São Paulo, 01221020, Brazil

RECRUITING

Related Publications (3)

• Goudouris ES, Rego Silva AM, Ouricuri AL, Grumach AS, Condino-Neto A, Costa-Carvalho BT, Prando CC, Kokron CM, Vasconcelos DM, Tavares FS, Silva Segundo GR, Barreto IC, Dorna MB, Barros MA, Forte WCN. II Brazilian Consensus on the use of human immunoglobulin in patients with primary immunodeficiencies. Einstein (Sao Paulo). 2017;15(1):1-16. doi: 10.1590/S1679-45082017AE3844.

  PMID: 28444082 BACKGROUND

• Perez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, El-Gamal Y, Harville TO, Hossny E, Mazer B, Nelson R, Secord E, Jordan SC, Stiehm ER, Vo AA, Ballow M. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017 Mar;139(3S):S1-S46. doi: 10.1016/j.jaci.2016.09.023. Epub 2016 Dec 29.

  PMID: 28041678 BACKGROUND

• Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med. 1991 Jul 11;325(2):110-7. doi: 10.1056/NEJM199107113250207. No abstract available.

  PMID: 2052044 BACKGROUND

Related Links

• Sponsor´s website

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

V-Set Domain-Containing T-Cell Activation Inhibitor 1

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; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

B7 Antigens; Intercellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors

Study Officials

• Sandra Regina Loggetto, PhD

  HCor Research Institute

  PRINCIPAL INVESTIGATOR

• Israel Silva Maia, PhD

  HCor research institute

  STUDY DIRECTOR

Central Study Contacts

Israel Silva Maia, PhD

CONTACT

+55-48-9-8413-1510; ismaia@hcor.com.br

Sandra Regina Loggetto, PhD

CONTACT

+55-11-9-7622-5837; loggetto.sr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: No mask is possible with this intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will get the same intervention: IV immunoglobulin for 2 consecutive days. Participants meeting the inclusion criteria will receive V-IMMUNE® at a dose of 1 g/kg once daily for two consecutive days, with infusion rates progressively increased to a maximum of 0.06 mL/kg/min, provided no adverse events occur. Pre-medication with intravenous normal saline and diphenhydramine is administered to mitigate infusion-related risks.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 8, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): February 27, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)