Trial Profile
Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 25 Oct 2023
Price :
$35
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At a glance
- Drugs Immune globulin (Primary)
- Indications Immunodeficiency disorders
- Focus Therapeutic Use
- Sponsors Baxalta; Shire; Takeda
- 11 Apr 2023 According to a Takeda media release, based on this trial the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) to expand the use of HYQVIA to treat primary immunodeficiency (PI) in children 2-16 years old
- 28 Sep 2022 Status changed from active, no longer recruiting to completed.
- 27 Apr 2020 Planned End Date changed from 30 Oct 2023 to 31 May 2023.