Status:
RECRUITING
V-IMMUNE® for Immune Thrombocytopenia
Lead Sponsor:
On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Collaborating Sponsors:
Hospital do Coracao
Conditions:
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
1+ years
Phase:
PHASE3
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 ...
Detailed Description
TIP Study 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 thrombocyto...
Eligibility Criteria
Inclusion
- Age ≥1 year;
- Confirmed diagnosis of immune thrombocytopenia (acute or chronic);
- Platelet count ≤20,000/mm³ at the time of enrollment;
- No other conditions that, in the investigator's opinion, could cause thrombocytopenia;
- For female patients, agreement to use regular contraceptive methods for the duration of the study.
Exclusion
- 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
- Serum creatinine \>2× the upper limit of normal
- BUN \>2.5× the upper limit of normal
- 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
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2027
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06962631
Start Date
July 18 2025
End Date
February 27 2027
Last Update
July 29 2025
Active Locations (2)
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1
IMIP Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil, 50070-902
2
Santa Casa de Misericórida de São Paulo
São Paulo, São Paulo, Brazil, 01221020