Pilot randomized, non-inferiority, cross-over trial of once-weekly vs. three times-weekly recombinant factor VIII prophylaxis in adults with severe haemophilia A

被引：3

作者：

Ragni, M. V. ^{[1
,2
]}

Yabes, J. G. ^{[3
]}

Fogarty, P. F. ^{[4
,10
]}

Josephson, N. C. ^{[5
]}

Kessler, C. M. ^{[6
]}

Neff, A. T. ^{[7
,11
]}

Raffini, L. ^{[8
]}

Brummel-Ziedins, K. ^{[9
]}

Moore, C. G. ^{[3
,12
]}

机构：

[1] Univ Pittsburgh, Dept Med, Med Ctr, Pittsburgh, PA USA

[2] Hemophilia Ctr Western Penn, Pittsburgh, PA USA

[3] Univ Pittsburgh, Ctr Res Hlth Care, Ctr Data, Pittsburgh, PA USA

[4] Univ Penn, Philadelphia, PA 19104 USA

[5] Puget Sound Blood Ctr, Seattle, WA 98104 USA

[6] Georgetown Univ, Med Ctr, Washington, DC 20007 USA

[7] Vanderbilt Univ, Med Ctr, Nashville, TN USA

[8] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA

[9] Univ Vermont, Dept Biochem, Colchester, VT USA

[10] Pfizer Inc, Collegeville, PA USA

[11] Cleveland Clin Fdn, 9500 Euclid Ave, Cleveland, OH 44195 USA

[12] Carolinas HealthCare Syst, Charlotte, NC USA

来源：

HAEMOPHILIA | 2017年 / 23卷 / 01期

基金：

美国国家卫生研究院;

关键词：

ADOLESCENT; DISEASE;

D O I：

10.1111/hae.13131

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：E43 / E46

页数：4

共 7 条

[1] Once-weekly prophylaxis with glycoPEGylated recombinant factor VIII (N8-GP) in severe haemophilia A: Safety and efficacy results from pathfinder 2 (randomized phase III trial)
Curry, Nicola
Albayrak, Canan
Escobar, Miguel
Holme, Pal Andre
Kearney, Susan
Klamroth, Robert
Misgav, Mudi
Negrier, Claude
Wheeler, Allison
Santagostino, Elena
Shima, Midori
Landorph, Andrea
Tonder, Sidsel Marie
Lentz, Steven R.
HAEMOPHILIA, 2019, 25 (03) : 373 - 381
[2] Experience with electronic patient diaries in a randomized, double-blind study of prophylaxis with once-weekly BAY 79-4980 vs. 3-times-weekly sucrose-formulated recombinant factor VIII
Schafer, K.
Tseneklidou-Stoeter, D.
Nelson, L.
Enriquez, M. Maas
HAEMOPHILIA, 2012, 18 : 25 - 26
[3] Pharmacokinetic results and correlations with intrinsic von Willebrand factor levels from a randomized, double-blind study of prophylaxis with once-weekly BAY 79-4980 vs. 3-times-weekly sucrose-formulated recombinant factor VIII
Martinowitz, U.
Windyga, J.
Powell, J.
Enriquez, M. Maas
Scharrer, I.
HAEMOPHILIA, 2012, 18 : 25 - 25
[4] Efficacy and safety of prophylaxis with once-weekly bay 79-4980 vs. three-times-weekly rFVIII-FS: a randomized, active-controlled, double-blind study
Powell, J.
Ingerslev, J.
Enriquez, M. M.
Martinowitz, U.
JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2011, 9 : 726 - 726
[5] Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART)
Manco-Johnson, M. J.
Kempton, C. L.
Reding, M. T.
Lissitchkov, T.
Goranov, S.
Gercheva, L.
Rusen, L.
Ghinea, M.
Uscatescu, V.
Rescia, V.
Hong, W.
JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2013, 11 (06) : 1119 - 1127
[6] Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART) (vol 11, pg 1119, 2013)
Manco-Johnson, M. J.
Kempton, C. L.
Reding, M. T.
Lissitchkov, T.
Goranov, S.
Gercheva, L.
Rusen, L.
Ghinea, M.
Uscatescu, V
Rescia, V
Hong, W.
JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2014, 12 (01) : 119 - 122
[7] A randomized, two-armed, double-blind, single-dose, cross-over, bioequivalence clinical trial to compare pharmacokinetic parameters and safety of recombinant human factor VIII with Fc fusion produced by AryoGen Pharmed Company versus Elocta® (reference product) in previously treated patients with severe haemophilia A
Eghbali, Aziz
Eshghi, Peyman
Toogeh, Gholamreza
Alavi, Samin
Badiei, Zahra
Ghanavat, Majid
Bordbar, Mohammadreza
Bazrafshan, Asghar
Karimi, Katayoon
Ahmadinejad, Minoo
Sabzvari, Araz
Kafi, Hamidreza
ANNALS OF HEMATOLOGY, 2025, : 1195 - 1202

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