A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A

About the trial

Sponsor

Baxalta now part of Shire (with Takeda Development Center Americas, Inc.)

Tested

PEGylated Recombinant Factor VIII (biological), ITI (biological)

Dates

Started 2015-11-12; completion 2024-10-29

Results posted

Yes

This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding. In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand). In case a participant develops antibodies, treatment will be provided as part of the study.

From ClinicalTrials.gov, last updated 2025-07-28. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Takeda Pharmaceuticals U.S.A., Inc. reported $178,203 in research payments for this study in 2025 (59 payments).

Products named: Adynovate, Takhzyro

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.