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Completed Phase 3 Interventional Results available

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects

ClinicalTrials.gov ID: NCT03277313

Public ClinicalTrials.gov record NCT03277313. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 11:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to acquire additional data on efficacy, safety, tolerability, immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to \<16 years) participants with primary immunodeficiency disease (PIDD).

Study identification

NCT ID
NCT03277313
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
44 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
2 Years to 15 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 25, 2017 (Actual)
Primary completion
Jul 20, 2022 (Actual)
Completion
Jul 20, 2022 (Actual)
Last update posted
Oct 23, 2023

2017 – 2022

United States locations

U.S. sites
19
U.S. states
13
U.S. cities
18
Facility City State ZIP Site status
University of Alabama Medical Center Birmingham Alabama 35294 —
Connecticut Children's Medical Center Hartford Connecticut 06106 —
University of Miami Pediatric Allergy and Immunology Miami Florida 33136 —
University of South Florida Physician Group St. Petersburg Florida 33701 —
Georgia Pollens Clinical Research Centers, Inc. Albany Georgia 31707 —
Emory Healthcare Atlanta Georgia 30322 —
Boston Children's Hospital Boston Massachusetts 02115 —
Washington University St Louis Missouri 63110 —
Women & Children's Hospital of Buffalo Buffalo New York 14203 —
Northwell Health, Inc. PRIME Great Neck New York 11021 —
Stony Brook Children's Hospital Stony Brook New York 11794 —
Carolinas Healthcare System Charlotte North Carolina 28203 —
Allergy Asthma & Immunology Relief of Charlotte Charlotte North Carolina 28277 —
OK Institute of Allergy & Asthma Clinical Research, LLC Oklahoma City Oklahoma 73131 —
Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma 74136 —
Allergy Partners of North Texas Research Dallas Texas 75230 —
University of Utah Salt Lake City Utah 84132 —
Section on Immunopathogenesis and Clinical Immunology Fairfax Virginia 22030 —
Marshall University Joan C. Edwards School of Medicine Charleston West Virginia 25701 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03277313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 23, 2023 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03277313 live on ClinicalTrials.gov.

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