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Your journey
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3Review
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More info
You can access this
clinical trial
if you have
Primary Immunodeficiency Disease
and you are
between 2 and 75
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 [NGAM-01]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.

Provided treatments

  • Biological: NewGam

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01313507. The sponsor of the trial is Octapharma and it is looking for 21 volunteers for the current phase.
Official trial title:
Clinical Study to Evaluate the Safety and Tolerability of Immunoglobulin Intravenous (Human) 10% (NewGam) Administered at High Infusion Rates to Patients With Primary Immunodeficiency Diseases (Extension of Study NGAM-01)