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Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A

by Quon, Doris V , Yang, Xinqun , Key, Nigel S , Lawal, Adebayo , Wong, Wing Y , O’Mahony, Brian , Ozelo, Margareth C , Symington, Emily , Henshaw, Joshua , Mahlangu, Johnny , Laffan, Michael , Pasi, K. John , Jayaram, Kala , Giermasz, Adam , Peerlinck, Kathelijne , Kaczmarek, Radoslaw , Leavitt, Andrew D , Pierce, Glenn F , Madan, Bella , Wang, Jiaan-Der , Kim, Benjamin , Huang, Mei , Pipe, Steven W

in Adult / Adverse events / Alanine / Alanine transaminase / Alanine Transaminase - blood / Anemia / Antibodies / Anticoagulants / Aspartate aminotransferase / Bleeding / Body weight / Coagulation factor VIII / Coagulation factors / Complementary DNA / Dependovirus / Disease prevention / Employees / Enrollments / Factor VIII - therapeutic use / Factor VIII deficiency / Gene Editing / Gene therapy / Genetic Therapy - methods / Genetic Vectors / Genetics / Genetics General / Genomes / Hematology / Hemophilia / Hemophilia A - complications / Hemophilia A - therapy / Hemorrhage - epidemiology / Hemorrhage - etiology / Hemorrhage - prevention & control / HIV / HIV Seronegativity / Human immunodeficiency virus / Humans / Hypotheses / Infusions, Intravenous / Intention to Treat Analysis / Laboratories / Male / Nausea / Oncology / Population / Safety / Thrombosis

2022

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2022

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2022

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Journal Article

Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A

Quon, Doris V,

Yang, Xinqun,

Key, Nigel S,

Lawal, Adebayo,

Wong, Wing Y,

O’Mahony, Brian,

Ozelo, Margareth C,

Symington, Emily,

Henshaw, Joshua,

Mahlangu, Johnny,

Laffan, Michael,

Pasi, K. John,

Jayaram, Kala,

Giermasz, Adam,

Peerlinck, Kathelijne,

Kaczmarek, Radoslaw,

Leavitt, Andrew D,

Pierce, Glenn F,

Madan, Bella,

Wang, Jiaan-Der,

Kim, Benjamin,

Huang, Mei,

Pipe, Steven W

2022

Overview

Patients with severe hemophilia A were treated with an adenoviral construct containing coagulation factor VIII cDNA and followed for 1 to 3 years. Median factor VIII activity at 49 to 52 weeks was 24 IU per deciliter, and annualized bleeding rates decreased after treatment. Elevations in alanine aminotransferase were the most common toxic effect and were mainly controlled with glucocorticoids.

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Publisher

Massachusetts Medical Society

Subject

Adult

/ Adverse events

/ Alanine

/ Alanine transaminase

/ Alanine Transaminase - blood

/ Anemia

/ Antibodies