Access the full text.
Sign up today, get DeepDyve free for 14 days.
P. Petrini, C. Rylander (2009)
Clinical safety surveillance study of the safety and efficacy of long‐term home treatment with ReFacto® utilizing a computer‐aided diary: a Nordic multicentre studyHaemophilia, 15
C. Rea, A. Dunkerley, B. Sørensen, S. Rangarajan (2009)
Pharmacokinetics, coagulation factor consumption and clinical efficacy in patients being switched from full‐length FVIII treatment to B‐domain‐deleted r‐FVIII and back to full‐length FVIIIHaemophilia, 15
A. Shirahata, K. Fukutake, J. Takamatsu, M. Shima, A. Yoshioka (2000)
Pharmacokinetics, prophylactic effects, and safety of a new recombinant FVIII formulated with sucrose (BAY 14-2222) in Japanese patients with hemophilia A.International journal of hematology, 72 1
T. Abshire, H. Brackmann, I. Scharrer, K. Hoots, C. Gazengel, J. Powell, E. Gorina, E. Kellermann, E. Vosburgh (2000)
Sucrose Formulated Recombinant Human Antihemophilic Factor VIII Is Safe and Efficacious for Treatment of Hemophilia A in Home TherapyThrombosis and Haemostasis, 83
M. Smith, P. Giangrande, H. Pollman, R. Littlewood, C. Kollmer, J. Feingold (2005)
A postmarketing surveillance study of the safety and efficacy of ReFacto® (St Louis‐derived active substance) in patients with haemophilia AHaemophilia, 11
K. Rothman, S. Greenland (2007)
Types of Epidemiologic Studies
B. Mei, C. Pan, Haiyan Jiang, H. Tjandra, Jonathan Strauss, Yaoqi Chen, Tongyao Liu, Xin Zhang, J. Severs, J. Newgren, Jianmin Chen, Jian-Ming Gu, B. Subramanyam, M. Fournel, G. Pierce, John Murphy (2010)
Rational design of a fully active, long-acting PEGylated factor VIII for hemophilia A treatment.Blood, 116 2
J. Ingerslev (2004)
FDA Workshop on factor VIII inhibitors held at the NIH, Bethesda, MA on 21 November 2003Haemophilia, 10
A. Yoshioka, M. Shima, K. Fukutake, J. Takamatsu, A. Shirahata (2001)
Safety and efficacy of a new recombinant FVIII formulated with sucrose (rFVIII–FS) in patients with haemophilia A: a long‐term, multicentre clinical study in JapanHaemophilia, 7
N. Bajwa, M. Enriquez, E. Gorina, G. Lemm (2009)
Cumulative analysis of inhibitor formation in patients with haemophilia A treated with sucrose‐formulated recombinant factor VIIIHaemophilia, 15
S. Paisley, J. Wight, E. Currie, C. Knight (2003)
The management of inhibitors in haemophilia A: introduction and systematic review of current practiceHaemophilia, 9
J. Young, H.‐C. Liu, E. Hsueh, Mei Huang, C. Peng, R-L Chen, M. Maas-Enriquez, K. Achilles (2009)
Efficacy and safety evaluation of sucrose‐formulated recombinant factor VIII for Taiwanese patients with haemophilia AHaemophilia, 15
M. Recht, L. Nemes, M. Matysiak, M. Manco‐Johnson, J. Lusher, M. Smith, P. Mannucci, C. Hay, T. Abshire, A. O’Brien, B. Hayward, C. Udata, D. Roth, S. Arkin (2009)
Clinical evaluation of moroctocog alfa (AF‐CC), a new generation of B‐domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: demonstration of safety, efficacy, and pharmacokinetic equivalence to full‐length recombinant factor VIIIHaemophilia, 15
A. Yoshioka, K. Fukutake, J. Takamatsu, A. Shirahata, Kogenate Group (2006)
Clinical Evaluation of Recombinant Factor VIII Preparation (Kogenate) in Previously Treated Patients with Hemophilia A: Descriptive Meta-Analysis of Post-Marketing Study DataInternational Journal of Hematology, 84
S. Courter, C.L Bedrosian (2001)
Clinical evaluation of B-domain deleted recombinant factor VIII in previously untreated patients.Seminars in hematology, 38 2 Suppl 4
C. Barnes, D. Lillicrap, J. Pazmino-Canizares, V. Blanchette, A. Stain, D. Clark, C. Hensmen, M. Carcao (2006)
Pharmacokinetics of recombinant factor VIII (Kogenate‐FS®) in children and causes of inter‐patient pharmacokinetic variabilityHaemophilia, 12
S. Pipe (2009)
Functional roles of the factor VIII B domainHaemophilia, 15
F. Rosendaal, H. Nieuwenhuis, H. Berg, H. Heijboer, E. Bunschoten, J. Meer, C. Smit, P. Strengers, E. Briet (1993)
A sudden increase in factor VIII inhibitor development in multitransfused hemophilia A patients in The Netherlands. Dutch Hemophilia Study Group.Blood, 81 8
Samantha Gouw1, H. 3 (2009)
The Multifactorial Etiology of Inhibitor Development in Hemophilia: Genetics and EnvironmentSemin Thromb Hemost, 35
G. Pasta, M. Mancuso, O. Perfetto, L. Solimeno (2008)
Synoviorthesis in haemophilia patients with inhibitorsHaemophilia, 14
Stroup (2000)
Meta‐analysis of observational studies in epidemiology: a proposal for reporting. Meta‐analysis Of Observational Studies in Epidemiology (MOOSE) groupJAMA, 283
E. Singleton, Jude Smith, M. Kavanagh, B. Nolan, B. White (2007)
Low risk of inhibitor formation in haemophilia patients after a change in treatment from Chinese hamster ovary cell-produced to baby hamster kidney cell-produced recombinant factor VIIIThrombosis and Haemostasis, 98
E. Aygören‐Pürsün, I. Scharrer (1997)
A Multicenter Pharmacosurveillance Study for the Evaluation of the Efficacy and Safety of Recombinant Factor VIII in the Treatment of Patients with Hemophilia AThrombosis and Haemostasis, 78
(2009)
Prospective study of inhibitor incidence with continuous infusion of factor concentrates during and after surgical procedures in patients with haemophilia A, B, or von Willebrand disease
G. White, D. DiMichele, K. Mertens, C. Négrier, I. Peake, C. Prowse, R. Schwaab, A. Yoshioka, J. Ingerslev (1999)
Utilization of Previously Treated Patients (PTPs), Noninfected Patients (NIPs), and Previously Untreated Patients (PUPs) in the Evaluation of New Factor VIII and Factor IX ConcentratesThrombosis and Haemostasis, 81
Wu (2008)
Inhibitor development in previously treated patients with hemophilia A after switch to recombinant factor VIIIHaemophilia, 14
Jerzy Windyga, L. Rusen, Ralph Gruppo, A. O’Brien, P. Kelly, D. Roth, S. Arkin (2010)
BDDrFVIII (Moroctocog alfa [AF‐CC]) for surgical haemostasis in patients with haemophilia A: results of a pivotal studyHaemophilia, 16
M. Wilkes, R. Navickis, W. Chan, E. Lewiecki (2010)
Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice versus randomized controlled trialsOsteoporosis International, 21
V. Blanchette, A. Shapiro, R. Liesner, F. Navarro, I. Warrier, P. Schroth, G. Spotts, B. Ewenstein (2008)
Plasma and albumin‐free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patientsJournal of Thrombosis and Haemostasis, 6
C. Négrier, A. Shapiro, E. Berntorp, I. Pabinger, M. Tarantino, A. Retzios, P. Schroth, B. Ewenstein (2008)
Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: Efficacy and safety of Advate in previously treated patientsThrombosis and Haemostasis, 100
C. Rothschild, I. Scharrer, H. Brackmann, N. Stieltjes, M. Vicariot, M. Torchet, W. Effenberger (2002)
European data of a clinical trial with a sucrose formulated recombinant factor VIII in previously treated haemophilia A patientsHaemophilia, 8
A. Shapiro, R. Gruppo, I. Pabinger, P. Collins, C. Hay, P. Schroth, K. Casey, L. Patrone, H. Ehrlich, B. Ewenstein (2009)
Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A.Expert opinion on biological therapy, 9 3
B. Neugebauer, C. Drai, M. Haase, A. Hilger, B. Keller-Stanislawski, P. Laitinen-Parkkonen, D. Mentzer, C. Rasmussen, C. Ratignier, R. Seitz (2007)
Factor VIII products and inhibitor development: concepts for revision of European regulatory guidelinesHaemophilia, 14
M. Rubinger, D. Lillicrap, G. Rivard, J. Teitel, M. Carcao, C. Hensman, I. Walker (2008)
A prospective surveillance study of factor VIII inhibitor development in the Canadian haemophilia A population following the switch to a recombinant factor VIII product formulated with sucroseHaemophilia, 14
J. Lusher, D. Roth (2005)
The safety and efficacy of B‐domain deleted recombinant factor VIII concentrates in patients with severe haemophilia A: an updateHaemophilia, 11
H. Pollmann, D. Externest, A. Ganser, B. Eifrig, Wolfhart Kreuz, H. Lenk, Ingrid Pabinger, Wolfgang Schramm, T. Schwarz, R. Zimmermann, Nicholas Zavazava, Johannes Oldenburg, R. Klamroth (2007)
Efficacy, safety and tolerability of recombinant factor VIII (REFACTO®) in patients with haemophilia A: interim data from a postmarketing surveillance study in Germany and AustriaHaemophilia, 13
Johannes Oldenburg, J. Goudemand, Leonard Valentino, M. Richards, Hue Luu, Alexander Kriukov, H. Gajek, Gerald Spotts, Bruce Ewenstein (2010)
Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin‐free method] demonstrates efficacy, safety and low‐risk for immunogenicity in routine clinical practiceHaemophilia, 16
(2009)
Impact of FVIII product change in severe haemophilia A patients previously treated with plasma-derived FVIII
Natascha Vidovic, R. Musso, R. Klamroth, M. Enriquez, K. Achilles (2010)
Postmarketing surveillance study of KOGENATE® Bayer with Bio‐Set® in patients with haemophilia A: evaluation of patients’ satisfaction after switch to the new reconstitution systemHaemophilia, 16
R. Schwartz, C. Abildgaard, L. Aledort, S. Arkin, A. Bloom, H. Brackmann, D. Brettler, H. Fukui, M. Hilgartner, M. Inwood, C. Kasper, P. Kernoff, P. Levine, J. Lusher, P. Mannucci, I. Scharrer, M. Mackenzie, Nazreen Pancham, Harng Kuo, R. Allred (1990)
Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. recombinant Factor VIII Study Group.The New England journal of medicine, 323 26
R. Musso, E. Santagostino, A. Faradji, A. Iorio, J. Meer, J. Ingerslev, T. Lambert, M. Maas-Enriquez, E. Gorina (2007)
Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: Experience in the standard clinical settingThrombosis and Haemostasis, 99
T. Yee, K. Pasi, P. Lilley, C. Lee (1999)
Factor VIII inhibitors in haemophiliacs: a single‐centre experience over 34 years, 1964–97British Journal of Haematology, 104
Roussel‐Robert (2003)
Factor VIII inhibitors development following introduction of B‐domain‐deleted recombinant factor VIII in four hemophilia A previously treated patientsJ Thromb Haemost, 1
K. Peerlinck, J. Arnout, J. Gilles, J. Saint-Remy, J. Vermylen (1993)
A Higher than Expected Incidence of Factor VIII Inhibitors in Multitransfused Haemophilia A Patients Treated with an Intermediate Purity Pasteurized Factor VIII ConcentrateThrombosis and Haemostasis, 69
V. Lecce, L. Loffredo, F. Fimognari, R. Cangemi, F. Violi (2003)
Factor VIII inhibitors development following introduction of B‐domain‐deleted recombinant factor VIII in four hemophilia A previously treated patientsJournal of Thrombosis and Haemostasis, 1
P. Collins, A. Faradji, M. Morfini, M. Enriquez, E. Gorina, L. Schwartz, G. Lemm (2008)
Efficacy and Safety of Secondary Prophylactic Versus On-Demand Sucrose-Formulated Recombinant Factor VIII Treatment in Adults with Severe Hemophilia A: Results from a 13-Month Crossover StudyBlood, 112
J. Lusher, C. Lee, C. Kessler, C. Bedrosian (2003)
The safety and efficacy of B‐domain deleted recombinant factor VIII concentrate in patients with severe haemophilia AHaemophilia, 9
Courter (2001)
Clinical evaluation of B‐domain deleted recombinant factor VIII in previously treated patientsSemin Hematol, 38
H. Fukui, A. Yoshioka, M. Shima, I. Tanaka, K. Koshihara, K. Fukutake, M. Fujimaki (1991)
Clinical evaluation of recombinant human factor VIII (BAY w 6240) in the treatment of hemophilia A.International journal of hematology, 54 5
Stephanie Seremetis, Jeanne Lusher, Charles Abildgaard, C. Kasper, R. Allred, D. Hurst (1999)
Human recombinant DNA‐derived antihaemophilic factor (factor VIII) in the treatment of haemophilia A: conclusions of a 5‐year study of home therapyHaemophilia, 5
Fukutake (2009)
Inhibitor formation with sucrose‐formulated recombinant factor VIII in patients with hemophilia A: results from postmarketing surveillance studiesJ Thromb Haemost, 7
G. White, S. Courter, G. Bray, Martin Lee, E. Gomperts (1997)
A Multicenter Study of Recombinant Factor VIII (RecombinateTM) in Previously Treated Patients with Hemophilia AThrombosis and Haemostasis, 77
(1981)
The patients.Transplantation proceedings, 13 1 Suppl 1
D. Keeling (2006)
Switching between full‐length and B‐domain‐deleted factor VIII and the risk of inhibitorsHaemophilia, 12
A. Gringeri, A. Tagliaferri, G. Tagariello, M. Morfini, E. Santagostino, P. Mannucci (2004)
Efficacy and inhibitor development in previously treated patients with haemophilia A switched to a B domain‐deleted recombinant factor VIIIBritish Journal of Haematology, 126
Lars Thim, Brian Vandahl, Johan Karlsson, N. Klausen, J. Pedersen, Thomas Krogh, M. Kjalke, J. Petersen, L. Johnsen, G. Bolt, P. Nørby, T. Steenstrup (2010)
Purification and characterization of a new recombinant factor VIII (N8)Haemophilia, 16
J. Delumeau, C. Ikegawa, ChisatoYo koyama, Verena Haupt (2008)
An observational study of sucrose-formulated recombinant factor VIII for Japanese patients with haemophilia AThrombosis and Haemostasis, 100
Alfonso Iorio, S. Halimeh, S. Holzhauer, N. Goldenberg, E. Marchesini, M. Marcucci, G. Young, C. Bidlingmaier, L. Brandão, C. Ettingshausen, A. Gringeri, G. Kenet, R. Knöfler, W. Kreuz, K. Kurnik, Daniela Manner, E. Santagostino, P. Mannucci, U. Nowak-Göttl (2010)
Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma‐derived or recombinant factor VIII concentrates: a systematic reviewJournal of Thrombosis and Haemostasis, 8
Jiangong Shi, Yupei Zhao, Junde Wu, Jing Sun, L. Wang, R. Yang (2007)
Safety and efficacy of a sucrose‐formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in ChinaHaemophilia, 13
J. Smolen, M. Schoels, Vivian Bykerk, Ernest Choy (2004)
Consensus StatementSpine Deformity, 3
M. Tarantino, Peter Collins, C. Hay, A. Shapiro, R. Gruppo, E. Berntorp, G. Bray, S. Tonetta, P. Schroth, A. Retzios, S. Rogy, M. Sensel, B. Ewenstein (2004)
Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin‐free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A 1Haemophilia, 10
J. Paola, M. Smith, R. Klamroth, P. Mannucci, C. Kollmer, J. Feingold, C. Kessler, H. Pollmann, M. Morfini, C. Udata, C. Rothschild, C. Hermans, R. Janco (2007)
ReFacto® 1 and Advate® 2 : a single‐dose, randomized, two‐period crossover pharmacokinetics study in subjects with haemophilia AHaemophilia, 13
K. Peerlinck, J. Arnout, M. Giambattista, J. Gilles, R. Laub, M. Jacquemin, J. Saint-Remy, J. Vermylen (1997)
Factor VIII Inhibitors in Previously Treated Haemophilia A Patients with a Double Virus-inactivated Plasma Derived Factor VIII ConcentrateThrombosis and Haemostasis, 77
Taki (2009)
Post‐authorization safety surveillance (PASS) program of antihemophilic factor (recombinant), plasma/albumin‐free method (rAHF‐PFM) for Japanese hemophilia A patientsJ Thromb Haemost, 7
I. Uijl, E. Mauser-Bunschoten, G. Roosendaal, R. Schutgens, K. Fischer (2009)
Efficacy assessment of a new clotting factor concentrate in haemophilia A patients, including prophylactic treatmentHaemophilia, 15
J. Astermark, Carmen Altisent, Angelika Batorova, M. Diniz, A. Gringeri, P. Holme, A. Karafoulidou, M. López-Fernández, B. Reipert, A. Rocino, M. Schiavoni, M. Depka, Jerzy Windyga, K. Fijnvandraat (2010)
Non‐genetic risk factors and the development of inhibitors in haemophilia: a comprehensive review and consensus reportHaemophilia, 16
P. Collins, A. Faradji, M. Morfini, M. Enriquez, L. Schwartz (2010)
Efficacy and safety of secondary prophylactic vs. on‐demand sucrose‐formulated recombinant factor VIII treatment in adults with severe hemophilia A: results from a 13‐month crossover studyJournal of Thrombosis and Haemostasis, 8
G. White, S. Courter, G. Bray, M. Lee, E. Gomperts (1997)
A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia A. The Recombinate Previously Treated Patient Study Group.Thrombosis and haemostasis, 77 4
C. Kempton (2010)
Inhibitors in previously treated patients: a review of the literatureHaemophilia, 16
A. Giles, G. Rivard, J. Teitel, I. Walker (1998)
Surveillance for factor VIII inhibitor development in the Canadian Hemophilia A population following the widespread introduction of recombinant factor VIII replacement therapy.Transfusion science, 19 2
C. Kempton, J. Soucie, T. Abshire (2006)
Incidence of inhibitors in a cohort of 838 males with hemophilia A previously treated with factor VIII concentratesJournal of Thrombosis and Haemostasis, 4
White White, DiMichele DiMichele, Mertens Mertens, Négrier Négrier, Peake Peake, Prowse Prowse, Schwaab Schwaab, Yoshioka Yoshioka, Ingerslev Ingerslev (1999)
Utilization of previously treated patients (PTPs), noninfected patients (NIPs), and previously untreated patients (PUPs) in the evaluation of new factor VIII and factor IX concentrates. Recommendation of the Scientific Subcommittee on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and HaemostasisThromb Haemost, 81
(2010)
Update of a long-term pharmacovigilance project: Helixate Ò NexGen for the treatment of hemophilia A
S. Courter, C. Bedrosian (2001)
Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients.Seminars in hematology, 38 2 Suppl 4
Journal of Thrombosis and Haemostasis – Unpaywall
Published: Nov 1, 2011
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.