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New treatment option for Immunodeficiencies
Official title V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
ClinicalTrials.gov ID: NCT06954441
What this study is testing
What is Intravenous immunoglobulin (IVIG)?
Intravenous immunoglobulin (IVIG) is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for immunodeficiencies.
Also referred to as V-IMMUNE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 primary immunodeficiency (PID). Participants, all aged ≥2 years and already receiving IVIG therapy, will be switched to V-IMMUNE® at a dose of 600 mg/kg every three weeks via intravenous infusion.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Patients aged 2 years or older;
- Primary immunoglobulin G deficiency, already receiving another intravenous immunoglobulin (IVIG). Primary IgG deficiency may be secondary...
- Agammaglobulinemia due to absence of B cells
- Hypogammaglobulinemia with reduced antibody function - variable common immunodeficiency complex
- Quantitative and functional deficiencies of immunoglobulin G
You likely can't join if
- 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
See the full eligibility criteria
- 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 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
- 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
- Selective 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...
The study team makes the final eligibility decision.
Where it's taking place
- Recife, Pernanbuco, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Recife, Pernanbuco, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.