Badri, Prajakta http://orcid.org/0000-0003-1248-616X
Habtemariam, Bahru
Melch, Megan
Clausen, Valerie A.
Arum, Seth
Li, Xingyu
Jay, Patrick Y.
Vest, John
Robbie, Gabriel J.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics and Pharmacodynamics of Patisiran in Patients with hATTR Amyloidosis and with Polyneuropathy After Liver Transplantation
https://doi.org/10.1007/s40262-023-01292-w
Funding for this research was provided by:
Alnylam Pharmaceuticals
Article History
Accepted: 24 July 2023
First Online: 28 August 2023
Declarations
:
: This work was supported by Alnylam Pharmaceuticals Inc. Alnylam Pharmaceuticals Inc. contributed to the study design, research, and interpretation of data, and the writing, reviewing, and approving of the manuscript for publication.
: Prajakta Badri, Bahru Habtemariam, Megan Melch, Valerie A. Clausen, Seth Arum, Xingyu Li, Patrick Y. Jay, John Vest, Gabriel J. Robbie are or were Alnylam Pharmaceutical employees and may hold Alnylam stocks or options.
: This study was conducted in accordance with the Good Clinical Practice Guideline as defined by the International Conference on Harmonisation, the Declaration of Helsinki, and all applicable federal and local regulations. The study was approved by independent institutional review boards.
: PB, MM and XL contributed to the data analyses for this manuscript, interpretation of results, writing and reviewing of the manuscript. BH, VC, SA, PJ, JV and GR contributed to the study design, interpretation of results, and writing and reviewing of the manuscript.
: Written informed consent was obtained from each subject before any study- related procedures were performed.
: The study protocol was approved by central and local institutional review boards and ethics committees. The study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.
: All participants provided written informed consent prior.
: All authors provide consent to publish these data.
: Not applicable.
: Anonymized individual participant data that support these results would be made available in a secure-access environment 12 months after study completion and when the product and indication have been approved for no less than 12 months in the USA and/or the EU. Access will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Requests for access to data can be submitted via the website ExternalRef removed.