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New IVIG therapy V-IMMUNE tested in phase III trial for immune deficiency

NCT ID NCT06954441

Recruiting now Disease control Sponsor: On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase III trial tests V-IMMUNE, an intravenous immunoglobulin (IVIG) product, in about 50 people with primary immunodeficiency (PID). Participants, aged 2 and older, will switch from their current IVIG to V-IMMUNE every three weeks for a year. The study aims to see if V-IMMUNE prevents serious bacterial infections and is safe, with a focus on infusion-related side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
V-IMMUNE (intravenous immunoglobulin, IVIG)
What this could lead to
If successful, this could provide a safe and effective immunoglobulin replacement option for people with primary immunodeficiency, helping prevent serious infections.
What could go wrong
This is a small, non-randomized trial using historical controls, so results may not be definitive. Infusion-related side effects and thromboembolic risks are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

agammaglobulinemia immunodeficiency disease inborn error of immunity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AGAMMAGLOBULINEMIA IMMUNODEFICIENCIES PRIMARY IMMUNODEFICIENCIES (PID)

Contacts and locations

Locations

  • IMIP Centro de Pesquisa

    RECRUITING

    Recife, Pernanbuco, 50070-902, Brazil

    Contact Email: •••••@•••••

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