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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
IMIP Instituto de Medicina Integral Professor Fernando Figueira
NOT_YET_RECRUITING
Recife
Santa Casa de Misericórida de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Israel Silva Maia, PhD
ismaia@hcor.com.br
+55-48-9-8413-1510
Backup
Sandra Regina Loggetto, PhD
loggetto.sr@hotmail.com
+55-11-9-7622-5837
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2027-02-27
Participants
Target number of participants: 31
Treatments
Experimental: Intervention arm
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
Sponsors
Collaborators: Hospital do Coracao
Leads: On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.

This content was sourced from clinicaltrials.gov