Status:
RECRUITING
V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
Lead Sponsor:
On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Collaborating Sponsors:
Hospital do Coracao
Conditions:
Immunodeficiencies
Primary Immunodeficiencies (PID)
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with ...
Detailed Description
Introduction: Immunoglobulin is used as a treatment for a variety of medical conditions, not only for its ability to combat infection as replacement therapy, but also for its anti-inflammatory and im...
Eligibility Criteria
Inclusion
- Patients aged 2 years or older;
- Primary immunoglobulin G deficiency, already receiving another intravenous immunoglobulin (IVIG). Primary IgG deficiency may be secondary (non-exhaustive list) to one of the following diagnoses:
- Agammaglobulinemia due to absence of B cells
- Hypogammaglobulinemia with reduced antibody function - variable common immunodeficiency complex
- Quantitative and functional deficiencies of immunoglobulin G
- Normal immunoglobulin with reduced capacity for antibody production after immunization (e.g., Wiskott-Aldrich syndrome, IgG subclass 2/4 deficiency, antipolysaccharide antibody deficiency against Haemophilus or pneumococcus)
- Severe combined immunodeficiencies: DiGeorge syndrome presenting with immunoglobulin G deficiency
- Isotype-switching defects: hyperimmunoglobulinemia M syndromes
- Two trough IgG measurements ≥500 mg/dL within the past 90 days.
- Participants with through IgG measurements ≥700 mg/dL within the last 30 days before the first visit
Exclusion
- Acute infection under treatment within 2 weeks prior to screening
- Pregnancy
- History of hypersensitivity reaction to blood or blood products
- Previous anaphylactic reaction to IgG
- Intolerance to any component of V-Immune
- IgA deficiency, history of reactions to products containing IgA, or history of anti-IgA antibodies
- Deficiency of IgA, IgM, IgD, or IgE
- Participation in any other study involving an investigational product
- Exposure to blood or any blood-derived products in the last 3 months
- Known HIV, HCV, or HBV infection
- ALT \>3× the upper limit of normal or 3x baseline value
- Serum creatinine \>2× the upper limit of normal or 2x baselline value
- BUN \>2.5× the upper limit of normal or 2.5x baseline value
- History of NYHA class III/IV heart failure
- Uncontrolled hypertension with systolic BP \>160 mmHg or diastolic BP \>100 mmHg
- History of thrombotic events such as DVT, MI, stroke, or PE within the last 6 months
- Neoplasia under treatment
- Severe hepatic, renal, or cardiac insufficiency
- Child-Pugh class B/C hepatic insufficiency
- Alcohol, opioid, or psychotropic drug abuse within the last 12 months
- Use of immunosuppressive agents
- Long-term use of prednisone \>10 mg/day or equivalent
- Protein-losing enteropathies (Crohn's disease, ulcerative colitis, Ménétrier's disease, celiac disease)
- Observation:
- If Research participant becomes pregnant during study participation - we will Discontinue any further administration of the IMP; The principal investigator must refer the research participant for follow-up through routine healthcare services; The research participant will continue to be monitored by the study; Obtain informed consent from the pregnant participant to request authorization to follow her pregnancy; If authorized by a specific informed consent form, even after the participant's involvement in the study has ended, the investigator must contact the pregnant participant quarterly to monitor the pregnancy. The results of this follow-up must be entered into the CRF. The frequency will be maintained as long as no abnormalities are identified in the participant, the pregnancy, or the fetus.
- Female partner of a male research participant becomes pregnant during the study = No action is required regarding the research participant's participation; Obtain informed consent from the research participant's partner to request authorization to monitor her pregnancy. If authorized by a specific informed consent form, the investigator must contact the pregnant woman quarterly to monitor the pregnancy. The results of this follow-up must be entered into the CRF. The frequency will be maintained as long as no abnormalities are identified in the pregnant woman, the pregnancy, or the fetus.
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06954441
Start Date
August 15 2025
End Date
February 27 2027
Last Update
August 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IMIP Centro de Pesquisa
Recife, Pernanbuco, Brazil, 50070-902