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Journal Articles

Efficacy and Safety of Giroctocogene Fitelparvovec in Adults with Moderately Severe to Severe Hemophilia Α: Primary Analysis Results from the Phase 3 ΑFFINE Gene Therapy Trial

Andrew D. Leavitt, Kaan Kavakli, Laurent Frenzel, Ali Bülent Antmen, Margareth Ozelo, Davide Matino, Hazza Alzahrani, Barbara A. Konkle, Steven W. Pipe, Jerome M. Teitel, Li-Jung Tseng, Annie F. Fang, Florence Ganne, Gregory Dirusso, Jeremy Rupon, Pascal Klaus, Jasmine Healy, Delphine Agathon, Francesca Biondo, Frank Plonski
Journal: Blood
Blood (2024) 144 (Supplement 1): 1053.
https://doi.org/10.1182/blood-2024-208486
Published: 2024
Journal Articles

Results from the Hemophilia Α Cohort of the Non-Investigational Lead-in Study: Prospective Collection of Bleeding Rate in Participants with Hemophilia Α Prior to Phase 3 Study (AFFINE) of Giroctocogene Fitelparvovec

Laurent Frenzel, Kaan Kavakli, Andrew D. Leavitt, Ali Bülent Antmen, Davide Matino, Margareth Ozelo, Hazza Alzahrani, Barbara A. Konkle, Maria de los Angeles Resa, Annie F. Fang, Jasmine Healy, Delphine Agathon, Francesca Biondo, Frank Plonski
Journal: Blood
Blood (2024) 144 (Supplement 1): 3575.
https://doi.org/10.1182/blood-2024-193368
Published: 2024
Journal Articles

Use of Fidanacogene Elaparvovec, a Gene Therapy Vector, to Deliver a Stable, Fully Functional Human Factor IX Transgene for the Treatment of Hemophilia B: A Combined Analysis of Safety

Ben Samelson-Jones, Laurent Frenzel, Kaan Kavakli, Adam Cuker, Jerome M. Teitel, Pengling Sun, Lisa J Wilcox, Francesca Biondo, Benjamin Hutter, John McKay, Delphine Agathon, Frank Plonski
Journal: Blood
Blood (2024) 144 (Supplement 1): 3577.
https://doi.org/10.1182/blood-2024-193453
Published: 2024
Journal Articles

Giroctocogene fitelparvovec gene therapy for severe hemophilia A: 104-week analysis of the phase 1/2 Alta study

Clinical Trials & Observations
Andrew D. Leavitt, Barbara A. Konkle, Kimo C. Stine, Nathan Visweshwar, Thomas J. Harrington, Adam Giermasz, Steven Arkin, Annie Fang, Frank Plonski, Anne Yver, Florence Ganne, Delphine Agathon, Maria de los Angeles Resa, Li-Jung Tseng, Gregory Di Russo, Bettina M. Cockroft, Liching Cao, Jeremy Rupon
Journal: Blood
Blood (2024) 143 (9): 796–806.
https://doi.org/10.1182/blood.2022018971
Published: 2024
Includes: Supplemental data
Journal Articles

Characterizing a Cohort of Patients with Hemophilia B Treated with Fidanacogene Elaparvovec from the Phase 3 Benegene-2 Study Who Returned to Factor IX Prophylaxis

Laurent Frenzel, Kaan Kavakli, Robert Klamroth, Shyh-Shin Chiou, Amy D. Shapiro, Pengling Sun, Joanne Fuiman, John McKay, Annie F. Fang, Francesca Biondo, Frank Plonski, Jeremy Rupon
Journal: Blood
Blood (2023) 142 (Supplement 1): 2257.
https://doi.org/10.1182/blood-2023-181223
Published: 2023
Journal Articles

Health-Related Quality of Life in Adults with Hemophilia B after Receiving Gene Therapy with Fidanacogene Elaparvovec

Sylvia von Mackensen, Jonathan M. Ducore, Lindsey A. George, Adam Giermasz, Catherine McGuinn, John E. J. Rasko, Ben J Samelson-Jones, Spencer K. Sullivan, Jerome M. Teitel, Amit Chhabra, Annie F. Fang, Amanda O'Brien, Frank Plonski, Jeremy Rupon, Lynne Smith, Ian Winburn
Journal: Blood
Blood (2023) 142 (Supplement 1): 3628.
https://doi.org/10.1182/blood-2023-179431
Published: 2023
Journal Articles

Four-Year Follow-up of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia Α

Thomas J. Harrington, Adam Giermasz, Nathan Visweshwar, Andrew D. Leavitt, Barbara A. Konkle, Jeremy Rupon, Gregory Dirusso, Li-Jung Tseng, Maria de los Angeles Resa, Florence Ganne, Delphine Agathon, Frank Plonski, Didier Rouy, Bettina M. Cockroft, Annie F. Fang, Steven Arkin
Journal: Blood
Blood (2023) 142 (Supplement 1): 1054.
https://doi.org/10.1182/blood-2023-179422
Published: 2023
Journal Articles

Updated Results of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia Α

Adam Giermasz, Nathan Visweshwar, Thomas J. Harrington, Andrew D Leavitt, Barbara Konkle, Jeremy Rupon, Gregory Di Russo, Li-Jung Tseng, Maria de los Angeles Resa, Florence Ganne, Delphine Agathon, Frank Plonski, Didier Rouy, Bettina M. Cockroft, Annie Fang, Steven Arkin
Journal: Blood
Blood (2022) 140 (Supplement 1): 7776–7777.
https://doi.org/10.1182/blood-2022-159421
Published: 2022
Journal Articles

Updated Results of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia a

Nathan Visweshwar, Thomas J. Harrington, Andrew D Leavitt, Barbara A. Konkle, Adam Giermasz, Kimo Stine, Jeremy Rupon, Gregory Di Russo, Li-Jung Tseng, Maria de los Angeles Resa, Florence Ganne, Delphine Agathon, Frank Plonski, Didier Rouy, Bettina M. Cockroft, Annie Fang, Steven Arkin
Journal: Blood
Blood (2021) 138 (Supplement 1): 564.
https://doi.org/10.1182/blood-2021-148651
Published: 2021
Journal Articles

Updated Follow-up of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (SB-525) Gene Therapy in Adults with Severe Hemophilia a

Andrew D. Leavitt, MD, Barbara A. Konkle, MD, Kimo Stine, MD, Nathan Visweshwar, MD, Thomas J. Harrington, MD, Adam Giermasz, MD PhD, Steven Arkin, MD, Annie Fang, MD PhD, Frank Plonski, RN, MA, Lynne Smith, MBA, Li-Jung Tseng, PhD MBA, Gregory Di Russo, MD, Bettina M Cockroft, MD, Jeremy Rupon, MD, Didier Rouy, MD PhD
Journal: Blood
Blood (2020) 136 (Supplement 1): 12.
https://doi.org/10.1182/blood-2020-137648
Published: 2020