MedTrace Logo

Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects

NCT03116347 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-01-11

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to \<18 years) patients with Primary Immunodeficiency Diseases (PIDD)

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

HYQVIA

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

BIOLOGICAL

KIOVIG

100 mg/ml solution for Immune Globulin Intravenous Infusion

BIOLOGICAL

Cuvitru

200 mg/ml solution for Immune Globulin Subcutaneous Injection

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2021-01-15
Completion
2021-01-15

Countries

  • Czechia
  • Denmark
  • France
  • Greece
  • Hungary
  • Slovakia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03116347 on ClinicalTrials.gov