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Authors
Wojciechowski, Jessica https://orcid.org/0000-0002-3302-8742
Gaitonde, Puneet https://orcid.org/0009-0009-5617-5495
Hughes, Jim H. https://orcid.org/0000-0002-1862-5805
Ravva, Patanjali
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Clinical Trials BETA
Clinical trials referenced in this document:
nct00364182 at ClinicalTrials.govnct01335061 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
nct00037557 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
nct00093171 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
nct00093210 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
nct03861273 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
nct03307980 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
nct02484092 at ClinicalTrials.govDocuments that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
Documents that mention this clinical trial
Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B
https://doi.org/10.1007/s40262-025-01535-y
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Funding
Funding for this research was provided by:
Pfizer
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Article History
Accepted: 21 May 2025
First Online: 1 August 2025
Declarations
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: This study was sponsored by Pfizer.
: Jessica Wojciechowski was employed at Pfizer at the time of this study. Puneet Gaitonde, Jim H. Hughes, and Patanjali Ravva are employees of and shareholders in Pfizer.
: All clinical trials were approved by the appropriate local Independent Ethics Committee (IEC) or Institutional Review Board (IRB) and informed consent was obtained from all participants. Trials were carried out in concordance with ICH Guidelines for Good Clinical Practice. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See for more information.
: The code for the final NONMEM® model is available in the electronic supplementary material.
: J.W. and P.G. conceived and designed the research; J.W. and J.H.H performed the data analysis and quality review; and J.W., P.G., and P.R. reviewed and interpreted the results. All authors critically made a substantial contribution in writing the paper, reviewed the manuscript, and approved the final version for submission.
: Consent was obtained from participants in all trials.
: Written informed consent was obtained for all participants before conducting any study procedures.
