V-IMMUNE® treatment for immune thrombocytopenia

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

This trial tests V-IMMUNE®, an intravenous human immunoglobulin, to raise platelet counts in people aged 1 year and older with immune thrombocytopenia and very low platelets.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA. (Academic / other)
• Drugs / interventions: rituximab, cyclophosphamide
• Locations: 2 sites (Recife, Pernambuco and 1 other locations)
• Trial ID: NCT06962631 on ClinicalTrials.gov

What this trial studies

V-IMMUNE® is a 5% human normal immunoglobulin given intravenously in a prospective multicenter, single-group Phase 3 study of children and adults with immune thrombocytopenia. Participants with confirmed ITP and platelet counts ≤20,000/mm³ receive V-IMMUNE® (administered per protocol, typically 1 g/kg) and are followed for platelet response and safety, with the primary endpoint being a platelet count ≥50,000/mm³ on or before Day 9 after the first infusion. The trial uses historical controls from the literature rather than a randomized control arm to judge efficacy. Safety exclusions include active sepsis, certain viral infections, IgA deficiency or anti‑IgA antibodies, pregnancy/lactation, recent immunotherapies, and significant organ dysfunction.

Who should consider this trial

Good fit: Ideal candidates are people aged ≥1 year with a confirmed diagnosis of ITP (newly diagnosed, persistent, or chronic) and a platelet count ≤20,000/mm³ who have no other conditions likely to cause thrombocytopenia.

Not a fit: Patients with non-immune thrombocytopenia, active sepsis, known IgA deficiency or anti‑IgA antibodies, uncontrolled major comorbidities, recent excluded immunotherapies, pregnancy or breastfeeding, or chronic viral infections are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, V-IMMUNE® could quickly raise platelet counts to levels that reduce bleeding risk and lessen the need for urgent interventions.

How similar studies have performed: High-dose intravenous immunoglobulin has a long history of producing rapid platelet rises in ITP, so similar approaches have been successful in prior studies.

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

Where this trial is running

Recife, Pernambuco and 1 other locations

• IMIP Instituto de Medicina Integral Professor Fernando Figueira — Recife, Pernambuco, Brazil (Not_yet_recruiting)
• Santa Casa de Misericórida de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Sandra Regina Loggetto, PhD — HCor Research Institute
• Study coordinator: Israel Silva Maia, PhD

Conditions Immune Thrombocytopenia; phase III; clinical trial; immune thrombocytopenia; human immunoglobulin; platelets