CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
HYQVIAbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03277313
NCT03277313Phase 3Completed
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Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases

Baxalta now part of Shire·interventional·Posted Sep 11, 2017·Updated Oct 23, 2023

In Brief

A Phase 3 clinical trial evaluating HYQVIA for Primary Immunodeficiency Diseases (PID). Completed, enrolled 44 participants across 19 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency Diseases (PID)
CountriesUnited States
CollaboratorsBaxalta Innovations GmbH, now part of Shire

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartSep 25, 2017
Primary CompletionJul 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.8 years ago

Interventions

HYQVIAbiological

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)