New shot could help Immune-Compromised patients fight infections
NCT ID NCT04640142
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial is testing a new medicine called Newnorm, a concentrated antibody solution given as a shot under the skin, in 50 people with primary immunodeficiency (a condition where the immune system doesn't work properly). The goal is to see if Newnorm can prevent serious bacterial infections and maintain protective antibody levels. Participants receive regular injections over the study period, and researchers track infection rates and 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
Newnorm (a 20% human immunoglobulin solution injected under the skin)
What this could lead to
If successful, this could provide a new, convenient option for people with primary immunodeficiency to receive regular antibody replacement therapy at home, reducing infection risk.
What could go wrong
This is a single-arm, open-label study with only 50 participants, so results may not apply broadly. Side effects like local reactions or allergic responses are possible.
Disclaimer
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Octapharma Research Site
Irvine, California, 92697, United States
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Octapharma Research Site
Centennial, Colorado, 80112, United States
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Octapharma Research Site
Port Saint Lucie, Florida, 34986, United States
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Octapharma Research Site
St. Petersburg, Florida, 33701, United States
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Octapharma Research Site
Chicago, Illinois, 60612, United States
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Octapharma Research Site
Overland Park, Kansas, 66211, United States
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Octapharma Research Site
Louisville, Kentucky, 40217, United States
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Octapharma Research Site
White Marsh, Maryland, 21162, United States
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Octapharma Research Site
Kansas City, Missouri, 64111, United States
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Octapharma Research Site
Omaha, Nebraska, 68046, United States
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Octapharma Research Site
Leipzig, 04129, Germany
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Octapharma Research Site
Munich, 80337, Germany
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Octapharma Research Site
Budapest, 1097, Hungary
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Octapharma Research Site
Debrecen, 4032, Hungary
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Octapharma Research Site
Naples, 80131, Italy
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Octapharma Research Site
Roma, 00161, Italy
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Octapharma Research Site
Roma, 133, Italy
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Octapharma Research Site
Treviso, 31100, Italy
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Octapharma Research Site
Krakow, 30-663, Poland
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Octapharma Research Site
Bratislava, 833 40, Slovakia
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Octapharma Research Site
Kyiv, 04209, Ukraine
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Octapharma Research Site
Lviv, 79010, Ukraine
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Octapharma Research Site
Lviv, 79035, Ukraine