NCT03277313

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
BIOLOGICAL	HYQVIA	Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)

Timeline

• Start date: 2017-09-25
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2017-09-11
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study