Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study
Introduction The efficacy and safety of recombinant factor VIII Fc fusion protein (rFVIIIFc) as an extended half‐life treatment for severe haemophilia A were demonstrated in the Phase 3 A‐LONG and Kids A‐LONG studies. Eligible subjects who completed A‐LONG and Kids A‐LONG could enrol in ASPIRE (NCT0...
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| Veröffentlicht in: | Haemophilia : the official journal of the World Federation of Hemophilia 2020-05, Vol.26 (3), p.494-502 |
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| creator | Nolan, Beatrice Mahlangu, Johnny Pabinger, Ingrid Young, Guy Konkle, Barbara A. Barnes, Chris Nogami, Keiji Santagostino, Elena Pasi, K. John Khoo, Liane Winding, Bent Yuan, Huixing Fruebis, Joachim Rudin, Dan Oldenburg, Johannes |
| description | Introduction
The efficacy and safety of recombinant factor VIII Fc fusion protein (rFVIIIFc) as an extended half‐life treatment for severe haemophilia A were demonstrated in the Phase 3 A‐LONG and Kids A‐LONG studies. Eligible subjects who completed A‐LONG and Kids A‐LONG could enrol in ASPIRE (NCT01454739), an open‐label extension study.
Aim
To report the long‐term safety and efficacy of rFVIIIFc in subjects with severe haemophilia A who enrolled in ASPIRE.
Methods
Previously treated subjects received one or more of the following regimens: individualized prophylaxis (IP), weekly prophylaxis, modified prophylaxis or episodic treatment. Subjects could switch treatment regimen at any time. The primary endpoint was inhibitor development.
Results
A total of 150 subjects from A‐LONG and 61 subjects from Kids A‐LONG enrolled in ASPIRE. Most subjects received the IP regimen (A‐LONG: n = 110; Kids A‐LONG: n = 59). Median (range) treatment duration in ASPIRE for subjects from A‐LONG and Kids A‐LONG was 3.9 (0.1‐5.3) years and 3.2 (0.3‐3.9) years, respectively. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐5.2) and the overall rFVIIIFc safety profile was consistent with prior studies. For subjects on the IP regimen, annualized bleed rates (ABR) remained low (median overall ABR for adults and adolescents was |
| doi_str_mv | 10.1111/hae.13953 |
| format | Article |
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The efficacy and safety of recombinant factor VIII Fc fusion protein (rFVIIIFc) as an extended half‐life treatment for severe haemophilia A were demonstrated in the Phase 3 A‐LONG and Kids A‐LONG studies. Eligible subjects who completed A‐LONG and Kids A‐LONG could enrol in ASPIRE (NCT01454739), an open‐label extension study.
Aim
To report the long‐term safety and efficacy of rFVIIIFc in subjects with severe haemophilia A who enrolled in ASPIRE.
Methods
Previously treated subjects received one or more of the following regimens: individualized prophylaxis (IP), weekly prophylaxis, modified prophylaxis or episodic treatment. Subjects could switch treatment regimen at any time. The primary endpoint was inhibitor development.
Results
A total of 150 subjects from A‐LONG and 61 subjects from Kids A‐LONG enrolled in ASPIRE. Most subjects received the IP regimen (A‐LONG: n = 110; Kids A‐LONG: n = 59). Median (range) treatment duration in ASPIRE for subjects from A‐LONG and Kids A‐LONG was 3.9 (0.1‐5.3) years and 3.2 (0.3‐3.9) years, respectively. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐5.2) and the overall rFVIIIFc safety profile was consistent with prior studies. For subjects on the IP regimen, annualized bleed rates (ABR) remained low (median overall ABR for adults and adolescents was <1.0) and extended‐dosing intervals were maintained (median of 3.5 days) for the majority of subjects in ASPIRE.
Conclusion
ASPIRE results, which include up to 5 years of follow‐up data, confirm earlier reports on the consistent and well‐characterized safety and efficacy of rFVIIIFc treatment for severe haemophilia A.</description><identifier>ISSN: 1351-8216</identifier><identifier>EISSN: 1365-2516</identifier><identifier>DOI: 10.1111/hae.13953</identifier><identifier>PMID: 32227570</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adolescent ; Adult ; Aged ; bleed rate ; Child ; Child, Preschool ; Coagulation factors ; extended half‐life ; Factor VIII - pharmacology ; Factor VIII - therapeutic use ; Factor VIII deficiency ; Fc receptors ; Female ; Fusion protein ; Hemophilia ; Hemophilia A - drug therapy ; Humans ; Immunoglobulin Fc Fragments - pharmacology ; Immunoglobulin Fc Fragments - therapeutic use ; individualized prophylaxis ; Male ; Middle Aged ; Original ; perioperative haemostasis ; Prophylaxis ; Recombinant Fusion Proteins - pharmacology ; Recombinant Fusion Proteins - therapeutic use ; rFVIIIFc ; Safety ; Treatment Outcome ; Young Adult</subject><ispartof>Haemophilia : the official journal of the World Federation of Hemophilia, 2020-05, Vol.26 (3), p.494-502</ispartof><rights>2020 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2020 The Authors. Haemophilia published by John Wiley & Sons Ltd.</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4433-641d3917827a49ef8e02aa48786d5a4459c03ab9d53816e351dbe7fed95b5b663</citedby><cites>FETCH-LOGICAL-c4433-641d3917827a49ef8e02aa48786d5a4459c03ab9d53816e351dbe7fed95b5b663</cites><orcidid>0000-0001-5781-7669 ; 0000-0002-3959-8797 ; 0000-0003-3038-2145 ; 0000-0002-2415-2194 ; 0000-0003-0145-4736 ; 0000-0003-3394-2099 ; 0000-0001-6013-1254</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhae.13953$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhae.13953$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32227570$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nolan, Beatrice</creatorcontrib><creatorcontrib>Mahlangu, Johnny</creatorcontrib><creatorcontrib>Pabinger, Ingrid</creatorcontrib><creatorcontrib>Young, Guy</creatorcontrib><creatorcontrib>Konkle, Barbara A.</creatorcontrib><creatorcontrib>Barnes, Chris</creatorcontrib><creatorcontrib>Nogami, Keiji</creatorcontrib><creatorcontrib>Santagostino, Elena</creatorcontrib><creatorcontrib>Pasi, K. John</creatorcontrib><creatorcontrib>Khoo, Liane</creatorcontrib><creatorcontrib>Winding, Bent</creatorcontrib><creatorcontrib>Yuan, Huixing</creatorcontrib><creatorcontrib>Fruebis, Joachim</creatorcontrib><creatorcontrib>Rudin, Dan</creatorcontrib><creatorcontrib>Oldenburg, Johannes</creatorcontrib><title>Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study</title><title>Haemophilia : the official journal of the World Federation of Hemophilia</title><addtitle>Haemophilia</addtitle><description>Introduction
The efficacy and safety of recombinant factor VIII Fc fusion protein (rFVIIIFc) as an extended half‐life treatment for severe haemophilia A were demonstrated in the Phase 3 A‐LONG and Kids A‐LONG studies. Eligible subjects who completed A‐LONG and Kids A‐LONG could enrol in ASPIRE (NCT01454739), an open‐label extension study.
Aim
To report the long‐term safety and efficacy of rFVIIIFc in subjects with severe haemophilia A who enrolled in ASPIRE.
Methods
Previously treated subjects received one or more of the following regimens: individualized prophylaxis (IP), weekly prophylaxis, modified prophylaxis or episodic treatment. Subjects could switch treatment regimen at any time. The primary endpoint was inhibitor development.
Results
A total of 150 subjects from A‐LONG and 61 subjects from Kids A‐LONG enrolled in ASPIRE. Most subjects received the IP regimen (A‐LONG: n = 110; Kids A‐LONG: n = 59). Median (range) treatment duration in ASPIRE for subjects from A‐LONG and Kids A‐LONG was 3.9 (0.1‐5.3) years and 3.2 (0.3‐3.9) years, respectively. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐5.2) and the overall rFVIIIFc safety profile was consistent with prior studies. For subjects on the IP regimen, annualized bleed rates (ABR) remained low (median overall ABR for adults and adolescents was <1.0) and extended‐dosing intervals were maintained (median of 3.5 days) for the majority of subjects in ASPIRE.
Conclusion
ASPIRE results, which include up to 5 years of follow‐up data, confirm earlier reports on the consistent and well‐characterized safety and efficacy of rFVIIIFc treatment for severe haemophilia A.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>bleed rate</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Coagulation factors</subject><subject>extended half‐life</subject><subject>Factor VIII - pharmacology</subject><subject>Factor VIII - therapeutic use</subject><subject>Factor VIII deficiency</subject><subject>Fc receptors</subject><subject>Female</subject><subject>Fusion protein</subject><subject>Hemophilia</subject><subject>Hemophilia A - drug therapy</subject><subject>Humans</subject><subject>Immunoglobulin Fc Fragments - pharmacology</subject><subject>Immunoglobulin Fc Fragments - therapeutic use</subject><subject>individualized prophylaxis</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>perioperative haemostasis</subject><subject>Prophylaxis</subject><subject>Recombinant Fusion Proteins - pharmacology</subject><subject>Recombinant Fusion Proteins - therapeutic use</subject><subject>rFVIIIFc</subject><subject>Safety</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1351-8216</issn><issn>1365-2516</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kUtv1DAURiMEog9Y8AeQJTawSOu3ExZIo2qGRqoEKo-t5STXjKskHmynMNv-cjwzpQIkvLGle3z03XuL4gXBZySf87WBM8JqwR4Vx4RJUVJB5OPdW5CyokQeFScx3mBMGMXyaXHEKKVKKHxc3F1D58fWTWZKyJou-YC-Nk2DVh2yc3R-QpvgE7gJ2VxKa0ApgEkjZN5bFOEWAqCcYPSbtRucQYu3aJV9AwoQ5yFFZIMf9z8Xnz4210sEPxNMe3VMc799VjyxZojw_P4-Lb6slp8vLsurD--bi8VV2XHOWCk56VlNVEWV4TXYCjA1hleqkr0wnIu6w8y0dS9YRSTk1vsWlIW-Fq1opWSnxbuDdzO3I_Rd7iCYQW-CG03Yam-c_rsyubX-5m-1YhXHjGTB63tB8N9niEmPLnYwDGYCP0dNM1cxqZjI6Kt_0Bs_hzyUTHEslaol3QnfHKgu-BgD2IcwBOvdZnWeq95vNrMv_0z_QP5eZQbOD8APN8D2_yZ9uVgelL8AFRytvg</recordid><startdate>202005</startdate><enddate>202005</enddate><creator>Nolan, Beatrice</creator><creator>Mahlangu, Johnny</creator><creator>Pabinger, Ingrid</creator><creator>Young, Guy</creator><creator>Konkle, Barbara A.</creator><creator>Barnes, Chris</creator><creator>Nogami, Keiji</creator><creator>Santagostino, Elena</creator><creator>Pasi, K. John</creator><creator>Khoo, Liane</creator><creator>Winding, Bent</creator><creator>Yuan, Huixing</creator><creator>Fruebis, Joachim</creator><creator>Rudin, Dan</creator><creator>Oldenburg, Johannes</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-5781-7669</orcidid><orcidid>https://orcid.org/0000-0002-3959-8797</orcidid><orcidid>https://orcid.org/0000-0003-3038-2145</orcidid><orcidid>https://orcid.org/0000-0002-2415-2194</orcidid><orcidid>https://orcid.org/0000-0003-0145-4736</orcidid><orcidid>https://orcid.org/0000-0003-3394-2099</orcidid><orcidid>https://orcid.org/0000-0001-6013-1254</orcidid></search><sort><creationdate>202005</creationdate><title>Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study</title><author>Nolan, Beatrice ; Mahlangu, Johnny ; Pabinger, Ingrid ; Young, Guy ; Konkle, Barbara A. ; Barnes, Chris ; Nogami, Keiji ; Santagostino, Elena ; Pasi, K. John ; Khoo, Liane ; Winding, Bent ; Yuan, Huixing ; Fruebis, Joachim ; Rudin, Dan ; Oldenburg, Johannes</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4433-641d3917827a49ef8e02aa48786d5a4459c03ab9d53816e351dbe7fed95b5b663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>bleed rate</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Coagulation factors</topic><topic>extended half‐life</topic><topic>Factor VIII - pharmacology</topic><topic>Factor VIII - therapeutic use</topic><topic>Factor VIII deficiency</topic><topic>Fc receptors</topic><topic>Female</topic><topic>Fusion protein</topic><topic>Hemophilia</topic><topic>Hemophilia A - drug therapy</topic><topic>Humans</topic><topic>Immunoglobulin Fc Fragments - pharmacology</topic><topic>Immunoglobulin Fc Fragments - therapeutic use</topic><topic>individualized prophylaxis</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>perioperative haemostasis</topic><topic>Prophylaxis</topic><topic>Recombinant Fusion Proteins - pharmacology</topic><topic>Recombinant Fusion Proteins - therapeutic use</topic><topic>rFVIIIFc</topic><topic>Safety</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nolan, Beatrice</creatorcontrib><creatorcontrib>Mahlangu, Johnny</creatorcontrib><creatorcontrib>Pabinger, Ingrid</creatorcontrib><creatorcontrib>Young, Guy</creatorcontrib><creatorcontrib>Konkle, Barbara A.</creatorcontrib><creatorcontrib>Barnes, Chris</creatorcontrib><creatorcontrib>Nogami, Keiji</creatorcontrib><creatorcontrib>Santagostino, Elena</creatorcontrib><creatorcontrib>Pasi, K. John</creatorcontrib><creatorcontrib>Khoo, Liane</creatorcontrib><creatorcontrib>Winding, Bent</creatorcontrib><creatorcontrib>Yuan, Huixing</creatorcontrib><creatorcontrib>Fruebis, Joachim</creatorcontrib><creatorcontrib>Rudin, Dan</creatorcontrib><creatorcontrib>Oldenburg, Johannes</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nolan, Beatrice</au><au>Mahlangu, Johnny</au><au>Pabinger, Ingrid</au><au>Young, Guy</au><au>Konkle, Barbara A.</au><au>Barnes, Chris</au><au>Nogami, Keiji</au><au>Santagostino, Elena</au><au>Pasi, K. John</au><au>Khoo, Liane</au><au>Winding, Bent</au><au>Yuan, Huixing</au><au>Fruebis, Joachim</au><au>Rudin, Dan</au><au>Oldenburg, Johannes</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study</atitle><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle><addtitle>Haemophilia</addtitle><date>2020-05</date><risdate>2020</risdate><volume>26</volume><issue>3</issue><spage>494</spage><epage>502</epage><pages>494-502</pages><issn>1351-8216</issn><eissn>1365-2516</eissn><abstract>Introduction
The efficacy and safety of recombinant factor VIII Fc fusion protein (rFVIIIFc) as an extended half‐life treatment for severe haemophilia A were demonstrated in the Phase 3 A‐LONG and Kids A‐LONG studies. Eligible subjects who completed A‐LONG and Kids A‐LONG could enrol in ASPIRE (NCT01454739), an open‐label extension study.
Aim
To report the long‐term safety and efficacy of rFVIIIFc in subjects with severe haemophilia A who enrolled in ASPIRE.
Methods
Previously treated subjects received one or more of the following regimens: individualized prophylaxis (IP), weekly prophylaxis, modified prophylaxis or episodic treatment. Subjects could switch treatment regimen at any time. The primary endpoint was inhibitor development.
Results
A total of 150 subjects from A‐LONG and 61 subjects from Kids A‐LONG enrolled in ASPIRE. Most subjects received the IP regimen (A‐LONG: n = 110; Kids A‐LONG: n = 59). Median (range) treatment duration in ASPIRE for subjects from A‐LONG and Kids A‐LONG was 3.9 (0.1‐5.3) years and 3.2 (0.3‐3.9) years, respectively. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐5.2) and the overall rFVIIIFc safety profile was consistent with prior studies. For subjects on the IP regimen, annualized bleed rates (ABR) remained low (median overall ABR for adults and adolescents was <1.0) and extended‐dosing intervals were maintained (median of 3.5 days) for the majority of subjects in ASPIRE.
Conclusion
ASPIRE results, which include up to 5 years of follow‐up data, confirm earlier reports on the consistent and well‐characterized safety and efficacy of rFVIIIFc treatment for severe haemophilia A.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32227570</pmid><doi>10.1111/hae.13953</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-5781-7669</orcidid><orcidid>https://orcid.org/0000-0002-3959-8797</orcidid><orcidid>https://orcid.org/0000-0003-3038-2145</orcidid><orcidid>https://orcid.org/0000-0002-2415-2194</orcidid><orcidid>https://orcid.org/0000-0003-0145-4736</orcidid><orcidid>https://orcid.org/0000-0003-3394-2099</orcidid><orcidid>https://orcid.org/0000-0001-6013-1254</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Haemophilia : the official journal of the World Federation of Hemophilia, 2020-05, Vol.26 (3), p.494-502 |
| issn | 1351-8216 1365-2516 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7384031 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adolescent Adult Aged bleed rate Child Child, Preschool Coagulation factors extended half‐life Factor VIII - pharmacology Factor VIII - therapeutic use Factor VIII deficiency Fc receptors Female Fusion protein Hemophilia Hemophilia A - drug therapy Humans Immunoglobulin Fc Fragments - pharmacology Immunoglobulin Fc Fragments - therapeutic use individualized prophylaxis Male Middle Aged Original perioperative haemostasis Prophylaxis Recombinant Fusion Proteins - pharmacology Recombinant Fusion Proteins - therapeutic use rFVIIIFc Safety Treatment Outcome Young Adult |
| title | Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study |
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