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New antibody therapy aims to shield kids with rare immune disease from deadly infections

NCT ID NCT04944979

Ongoing Disease control Sponsor: Kedrion S.p.A. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a medicine called Kedrion IVIG 10% in 30 children with primary immunodeficiency, a condition where the immune system doesn't work properly. The treatment is made from donated antibodies and is given through a vein to help prevent serious bacterial infections. Researchers are checking how well it works, how safe it is, and how the body processes it.

What this could mean

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

Active substance

Kedrion intravenous immunoglobulin (IVIg) 10%

What this could lead to

If successful, this could provide a new treatment option to help children with primary immunodeficiency fight off serious bacterial infections.

What could go wrong

This is a small, early-phase trial with only 30 participants, so results may not apply to all patients. IVIG therapy requires regular infusions and can cause side effects like headache, fever, or allergic reactions.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

agammaglobulinemia inborn error of immunity Primary Immunodeficiency Diseases

As listed by the trial registrant

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

PRIMARY IMMUNODEFICIENCY DISEASE

Contacts and locations

Locations

  • Asthma and Allergy Center - Toledo

    Toledo, Ohio, 43617, United States

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, Italy

  • Azienda Ospedaliero-Universitaria - Ospedale Pediatrico Meyer

    Florence, Italy

  • Benioff Children's Hospital - Mission Bay

    San Francisco, California, 94158, United States

  • Centro Hospitalar Lisboa Central - Hospital Dona Estefânia

    Lisbon, Portugal

  • Centro Hospitalar Universitário do Porto - Hospital Santo António

    Porto, Portugal

  • Children's City Clinical Hospital No. 9 named after G.N. Speransky, Moscow City Health Department

    Moscow, Russia

  • Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology

    Moscow, Russia

  • Duke Children's Hospital & Health Center

    Durham, North Carolina, 27706, United States

  • Dél-Pesti Centrumkórház - Országos Hematológiai És Infektológiai Intézet

    Budapest, Hungary

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinic

    Milan, Italy

  • Fondazione Policlinico Tor Vergata

    Roma, Italy

  • I.R.C.C.S. Istituto Giannina Gaslini

    Genova, Italy

  • IMMUNOe Health and Research Centers

    Centennial, Colorado, 80112, United States

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Roma, Italy

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • Louisiana State University Shreveport

    Shreveport, Louisiana, 71103, United States

  • Národný ústav detských chorôb (National Institute of Pediatric Diseases)

    Bratislava, Slovakia

  • SST Spedali Civili di Brescia

    Brescia, Italy

  • Velocity Clinical Research - MedPharmics - Lafayette

    Lafayette, Louisiana, 70508, United States

  • Vital Prospects Clinical Research Institute PC

    Tulsa, Oklahoma, 74136, United States