Khan, Aneal
Sirrs, Sandra M.
Bichet, Daniel G.
Morel, Chantal F.
Tocoian, Adina
Lan, Lan
West, Michael L. http://orcid.org/0000-0003-4897-1378
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
The Safety of Agalsidase Alfa Enzyme Replacement Therapy in Canadian Patients with Fabry Disease Following Implementation of a Bioreactor Process
https://doi.org/10.1007/s40268-021-00361-4
Funding for this research was provided by:
Shire Human Genetic Therapies, a Takeda company
Article History
Accepted: 25 August 2021
First Online: 20 September 2021
Declarations
:
: This study was funded by Shire Human Genetic Therapies, a Takeda company.
: Dr. Khan reports grants and personal fees from Takeda, outside of the submitted work. Dr. Sirrs reports grants from and advisory board participation for Sanofi Genzyme, grants and travel support from Takeda, and grants and travel support from Amicus, outside of the submitted work. Dr. Bichet reports grants and travel support from and speaker bureau participation for Amicus Therapeutics and Sanofi Genzyme, outside of the submitted work. Dr. Morel reports personal fees from Takeda, outside of the submitted work. Dr. Tocoian and Dr. Lan were employees of Takeda at the time of the study. Dr. West reports grants, personal fees, and travel support from Amicus Therapeutics, Idorsia, Protalix, Sanofi Genzyme, and Takeda, outside of the submitted work.
: This study was conducted according to the International Conference on Harmonization of Good Clinical Practice guidelines and the principles of the Declaration of Helsinki (ClinicalTrials.gov identifier NCT01298141). The study was approved by the relevant institutional review board.
: All patients (or their legal guardians/parents) provided written informed content before enrolling in the study.
: Not applicable.
: The datasets, including redacted study protocol, redacted statistical analysis plan, and individual participants’ data (after de-identification), behind the results reported in this article, will be available 3 months after the submission of a request through ExternalRef removed by researchers who provide a methodologically sound proposal in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
: Not applicable.
: AK, SMS, DGB, CFM, AT, LL, and MLW each provided substantial contributions to the interpretation of data for the work, drafted and revised the manuscript critically for important intellectual content, and approved the final version to be published. LL provided the statistical analysis of the data.