Fasshauer, Maria
Borte, Michael
Bitzenhofer, Michaela
Pausch, Christine
Pittrow, David
Park, Michelle
Gladiator, André
Jandus, Peter
Clinical trials referenced in this document:
Documents that mention this clinical trial
Real-World Use, Safety, and Patient Experience of 20% Subcutaneous Immunoglobulin for Primary Immunodeficiency Diseases
https://doi.org/10.1007/s12325-023-02649-0
Funding for this research was provided by:
Baxalta Innovations GmbH, a Takeda company
Takeda Pharmaceuticals International AG
Article History
Received: 8 June 2023
Accepted: 15 August 2023
First Online: 26 September 2023
Declarations
:
: Maria Fasshauer has participated in advisory boards for Baxalta/Shire, has received honoraria for lectures from CSL Behring and Shire, and has received travel grants from Octapharma until 2018. Michael Borte’s institution has received research grant support from Baxalta, CSL Behring, and Octapharma, and he has participated in advisory boards for CSL Behring, Octapharma, and Shire. Michaela Bitzenhofer has received a grant from Takeda. Christine Pausch has nothing to disclose. David Pittrow reports personal fees from Amgen, Aspen, Bayer, Biogen, Boehringer Ingelheim, Daiichi Sankyo, Janssen, MSD, Sandoz, and Sanofi Genzyme outside the submitted work. He has acted as a consultant for Baxalta. Michelle Park is an employee of Takeda Development Center Americas, Inc. and a Takeda shareholder. André Gladiator is an employee of Takeda Pharmaceuticals International AG and a Takeda shareholder. Peter Jandus has participated in advisory boards for AstraZeneca, CSL Behring, GSK, Sanofi, and Shire, has received honoraria for lectures from CSL Behring and Shire, has received travel grants from Biotest, CSL Behring, Octapharma, and Shire, and has received research grants to his institution from AstraZeneca, CSL Behring, Novartis, and Shire.
: This study was conducted in accordance with the International Council for Harmonization Good Clinical Practice, the Declaration of Helsinki 1964 and national and local laws and regulations. Ethics approval was given by the ethics committee of Saxony Physician Chamber and Swissethics (EK-BR-12/18-1). The study is registered in the German Clinical Trials Register under the identifier DRKS00014562. All patients or their legally authorized representative provided written informed consent to participate and consent for publication prior to study enrollment.