Efficacy of EHL N9-GP for on-demand treatment of bleeding episodes in hemophilia B: analysis of pivotal trial data

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Acknowledgments

The paradigm 2 trial was sponsored by Novo Nordisk A/S (Bagsværd, Denmark) and is registered with ClinicalTrials.gov (NCT01333111). The sponsor was responsible for trial operations, including data analysis. The authors acknowledge the medical writing assistance of Vathsala Jayanth (Parexel), which was funded by Novo Nordisk A/S.

Author contributions

MAE, CEW, and GY were principal investigators and enrolled and cared for patients during the trial. All authors designed the trial protocol, directed the data analysis, and wrote the manuscript. All authors had access to the primary clinical trial data. All authors were involved in interpretation of the trial results and preparation of the manuscript outline, provided input during the review stages, and approved the final manuscript. The authors assume full responsibility for the accuracy and completeness of the reported data, and agree to be accountable for all aspects of the work.

Disclosure

MAE reports research funding from Pfizer and consulting fees from CSL Behring, Genentech, Roche, Hemabiologics, Novo Nordisk, Pfizer, and Shire. MAE participated in advisory boards, consultation, and educational talks and received personal fees from Sanofi, Novo Nordisk, Takeda and CSL Behring. DLC is an employee of Novo Nordisk Inc. GY reports honoraria and consultancy fees from Alnylam, Bioverativ, CSL Behring, Genentech/Roche, Grifols, Kedrion, Novo Nordisk, and Shire. He also reports personal fees from Bioverativ/Sanofi, CSL Behring, Genentech/Roche, Grifols, Kedrion, Novo Nordisk, Spark, Takeda, and UniQure, during the conduct of the study. The authors report no other conflicts of interest in this work. 

Supplementary material

Table S1 List of independent ethics committees or institutional review boards that approved the paradigm 2 trial (NCT01333111)