V-IMMUNE® treatment for immune thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Santa Casa de Misericórida de São Paulo
  São Paulo, São Paulo, Brazil Recruiting
• IMIP Instituto de Medicina Integral Professor Fernando Figueira
  Recife, Pernambuco, Brazil Not yet recruiting

Study contacts

• Principal investigator: Sandra Regina Loggetto, PhD — HCor Research Institute
• Study coordinator: Israel Silva Maia, PhD
• Email: ismaia@hcor.com.br
• Phone: +55-48-9-8413-1510

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.