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Authors
Azimpour, Khashayar https://orcid.org/0000-0001-9226-0544
Dorling, Patricia
Koulinska, Irene
Kunduri, Swati
Lan, Zhiyi
Poritz, Julia
Tremblay, Gabriel
Raad-Faherty, Angie
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03018730 at ClinicalTrials.govnct02795676 at ClinicalTrials.govDocuments that mention this clinical trial
Health State Utility Values in Fabry Disease: Insights from the Pegunigalsidase Alfa Clinical Trials
https://doi.org/10.1007/s12325-024-03095-2
nct03180840 at ClinicalTrials.govDocuments that mention this clinical trial
Health State Utility Values in Fabry Disease: Insights from the Pegunigalsidase Alfa Clinical Trials
https://doi.org/10.1007/s12325-024-03095-2
Head-to-head trial of pegunigalsidase alfa versus agalsidase beta in patients with Fabry disease and deteriorating renal function: results from the 2-year randomised phase III BALANCE study
https://doi.org/10.1136/jmg-2023-109445
Documents that mention this clinical trial
Health State Utility Values in Fabry Disease: Insights from the Pegunigalsidase Alfa Clinical Trials
https://doi.org/10.1007/s12325-024-03095-2
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Funding
Funding for this research was provided by:
Chiesi USA
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Article History
Received: 24 April 2024
Accepted: 13 December 2024
First Online: 23 January 2025
Declarations
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: Khashayar Azimpour, Patricia Dorling, Irene Koulinska, and Swati Kunduri are employees of Chiesi. Zhiyi Lan, Julia Poritz, Gabriel Tremblay, and Angie Raad-Faherty are employees of Cytel Inc.; Chiesi commissioned Cytel Inc. for the study design, analysis, and development of the manuscript.
: Data in this article is not identifiable; therefore, ethics committee approval was not required for this study. For the BALANCE, BRIDGE, and BRIGHT studies, an institutional review board or independent ethics committee reviewed and approved the study protocol and any amendments prior to their implementation, each study was conducted in accordance with the Declaration of Helsinki, in compliance with the approved protocol, Good Clinical Practice guidelines, and applicable regulatory requirements. Written informed consent was obtained from all study participants of the BALANCE, BRIDGE, and BRIGHT studies that included permission to use study data in future analyses. Data from the BALANCE, BRIDGE, and BRIGHT studies was obtained and accessed via Chiesi Farmaceutici S.p.A. who are owners of the data.
