drugset / Trial / NCT03277313

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

NCT03277313

Non-randomizedSingle-groupOpen-labelPrevention

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).

Timeline

Start
2017-09-25
Primary completion
2022-07-20
Completion
2022-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Infusion 10% (Human) Protein / enzyme biologic Subcutaneous
Background rHuPH20 Protein / enzyme biologic Subcutaneous