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- Kovaltry (octocog alfa) / Bayer, CSL Behring, Haemoctin (human plasma derived coagulation factor VIII) / ADMA Biologics
Low resolution cryo-EM maps and AFM analysis combined with alpha fold model of full-length coagulation Factor VIII sheds light on the conformational positioning of the Factor VIII B domain (#51) (Spectrum (C2)) - Jan 7, 2023 - Abstract #GTH2023GTH_185;
Conclusion The FL-FVIII shows a significant amount of conformational variability, most of which is attributed to the disordered B domain. Glycosylation plays a key role in the folding and stabilization of the B domain with respect to the rest of the FL-FVIII.
- || Haemoctin (human plasma derived coagulation factor VIII) / ADMA Biologics, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
El mejor factor es el que llega a tu vena amigo. Acá solo plasmarico de Octanate y de Haemoctin para la Hemofilia A. (Twitter) - Nov 2, 2021
- | Enrollment change, Trial withdrawal: RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - Dec 17, 2020
P=N/A, N=0, Withdrawn, Sponsor: City of Hope Medical Center
Glycosylation plays a key role in the folding and stabilization of the B domain with respect to the rest of the FL-FVIII. N=148 --> 0 | Active, not recruiting --> Withdrawn
- || Trial completion, Trial completion date, Trial primary completion date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Dec 17, 2020
P=N/A, N=3, Completed, Sponsor: City of Hope Medical Center
N=148 --> 0 | Active, not recruiting --> Withdrawn Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Oct 2020 | Trial primary completion date: Jun 2020 --> Oct 2020
- | Haemoctin (human plasma derived coagulation factor VIII) / ADMA Biologics
Clinical, Journal: Long-Term Safety and Efficacy Data of a Plasma-Derived Factor VIII Concentrate with von Willebrand Factor for Treatment of Patients with Hemophilia A Covering 18 Years. (Pubmed Central) - Mar 31, 2020
We describe the results of the (to our knowledge) longest long-term noninterventional study so far performed to obtain real-life data on the treatment of hemophilia A patients with a single plasma-derived FVIII concentrate containing von Willebrand factor (pdFVIII; Haemoctin/Faktor VIII SDH Intersero)...Inhibitors were found in 13% (3/23) and high-titer inhibitors in 4% (1/23) of previously untreated patients with severe hemophilia A. Four previously treated patients with severe hemophilia A developed inhibitors, thereof three high-titer inhibitors (3.3 and 2.5 high-titer inhibitors in 1,000 patient-years). No unexpected adverse effect on the health of the patients, no pdFVIII-related thrombosis, thromboembolic event, or hypersensitivity reaction, and no suspected viral transmission related to pdFVIII were documented.
- NovoEight (turoctocog alfa) / Novo Nordisk
VWf containing therapeutic concentrates induce FXII activation, leading to kallikrein activation and bradykinin formation in vitro (Lloyd) - Dec 17, 2019 - Abstract #GTH2020GTH_28;
Further research aims to analyse the role of vWF FXII interaction in more detail. Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany
- || Trial initiation date: RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - Apr 11, 2017
P=N/A, N=148, Active, not recruiting, Sponsor: City of Hope Medical Center
Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany Initiation date: Jun 2009 --> Sep 2009
- Trial initiation date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Apr 11, 2017
P=N/A, N=3, Active, not recruiting, Sponsor: City of Hope Medical Center
Initiation date: Jun 2009 --> Sep 2009 Initiation date: Jun 2009 --> Sep 2009
- Enrollment closed, Trial primary completion date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Apr 1, 2015
P=N/A, N=3, Active, not recruiting, Sponsor: City of Hope Medical Center
Initiation date: Jun 2009 --> Sep 2009 Completed --> Active, not recruiting | Trial primary completion date: Feb 2015 --> Jun 2020
- Trial completion, Enrollment change, Trial primary completion date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Mar 5, 2015
P=N/A, N=3, Completed, Sponsor: City of Hope Medical Center
Completed --> Active, not recruiting | Trial primary completion date: Feb 2015 --> Jun 2020 Active, not recruiting --> Completed | N=50 --> 3 | Trial primary completion date: Jun 2020 --> Feb 2015
- Enrollment closed: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - May 4, 2014
P=N/A, N=50, Active, not recruiting, Sponsor: City of Hope Medical Center
Active, not recruiting --> Completed | N=50 --> 3 | Trial primary completion date: Jun 2020 --> Feb 2015 Recruiting --> Active, not recruiting
- || Enrollment closed: RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - May 16, 2013
P=N/A, N=148, Active, not recruiting, Sponsor: City of Hope Medical Center
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting