drugset

drugset / Trial / NCT03116347

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

NCT03116347 ↗

Phase 4 Completed 42 enrolled Baxalta now part of Shire Baxalta Innovations GmbH, now part of Shire · collab

Non-randomizedSingle-groupOpen-labelTreatment

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)

Timeline

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

Publications

Ciznar P, Roderick M, Schneiderova H, Jesenak M, Krivan G, Brodszki N, Jolles S, Atisso C, Fielhauer K, Saeed-Khawaja S, McCoy B, Yel L. fSCIG 10% in pediatric primary immunodeficiency diseases: a European post-authorization safety study. Allergy Asthma Clin Immunol. 2024 Sep 17;20(1):47. doi: 10.1186/s13223-024-00904-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cuvitru	Protein / enzyme biologic	200 mg/ml	Subcutaneous
Subject	HYQVIA	Protein / enzyme biologic	10 %	Subcutaneous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	100 mg/ml	Intravenous

Indications