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- Obizur (susoctocog alfa) / Takeda, Ipsen
[VIRTUAL] Real World Experience on Use of Susoctocog-alfa (rpFVIII) in the Treatment of a Population of Italian Elderly Patients with Acquired Haemophilia A (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_779;
Our report showed that susoctocog-alfa may be an effective and safe option for patients with AHA, especially those presenting severe co-morbidities, also if used at a lower dosage than recommended.
- Obizur (susoctocog alfa) / Takeda, Ipsen
[VIRTUAL] Real-World Use of Recombinant B-Domain-Deleted, Porcine-Sequence Factor VIII in Patients with Acquired Hemophilia A: An Interim Analysis of the Post-Authorization Safety Study in the European Union (EU) (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_763;
P=N/A
Background: Antihemophilic factor VIII (recombinant), porcine sequence (susoctocog alfa, OBI-1, BAX 801, TAK-672; Baxalta US Inc., a Takeda company, Lexington, MA, USA; recombinant porcine FVIII [rpFVIII]) has low cross-reactivity with anti-human FVIII antibodies, and can be used to treat bleeding episodes (BEs) in adults with acquired hemophilia A (AHA)... In this interim analysis, these real-world data demonstrate an acceptable safety and effectiveness profile for rpFVIII in controlling bleeds in patients with AHA, and provide insights into how rpFVIII use may be optimized to personalize therapy.
- Obizur (susoctocog alfa) / Takeda, Ipsen
[VIRTUAL] In vitro Correction of Thrombin Generation by Recombinant Porcine Factor VIII (rpFVIII) in Plasma Containing Anti-Factor VIII Inhibitory Antibodies (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_759;
rpFVIII correction of thrombin generation appears to be dependent on the anti-porcine inhibitory antibody titer and not on the anti-human inhibitory titer. Consistent with real-world observations, presence of pre-existing FVIII inhibitors does not exclude a positive response to rpFVIII.
- cyclophosphamide intravenous / Generic mfg., Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
[VIRTUAL] A Rare Case of Acquired Haemophilia A with Platelet Dysfunction Associated with Non Hodgkin Indolent Lymphoma (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_758;
This rare and complex case underlines the need of multiple diagnostic and therapeutical approaches to AHA, due to the combination of coagulation and platelet dysfunction. Our case, suggest also the usefulness of Rituximab when used early in AHA secondary to lymphoproliferative disorders.
- Obizur (susoctocog alfa) / Takeda, Ipsen
[VIRTUAL] The successful use of susoctocog-alfa (rpFVIII) in the treatment of nine elderly patients presenting acquired haemophilia A: a multicenter case series () - May 12, 2020 - Abstract #WFH2020WFH_15;
Our case, suggest also the usefulness of Rituximab when used early in AHA secondary to lymphoproliferative disorders. Our report showed that susoctocog-alfa may be an effective and safe option for patients with AHA, especially those with concomitant cardiovascular diseases, also if used at a lower dosage than recommended.
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Journal: Identification of a Novel Transcription Factor Required For Osteogenic Differentiation Of Mesenchymal Stem Cells. (Pubmed Central) - Mar 14, 2020
ObI-1 stimulates bone-morphogenetic protein (BMP)-4 expression and the consequent activation of the Smad pathway; treatment with a BMP receptor-type I antagonist completely abolishes ObI-1-mediated stimulation of osteogenic differentiation. Collectively, our findings suggest that ObI-1 modulates osteogenic differentiation, at least in part, through the BMP signaling pathway, increasing Runx2 activation and leading to osteoblast commitment and maturation.
- | Journal: New Hemostatic Agents: Perioperative Anesthetic Considerations. (Pubmed Central) - Mar 10, 2020
Implementation into clinical practice requires their availability and user knowledge. Sustainability of these new drugs will depend on post-licensing research, cost-effectiveness, and clinical experience.
- ||| Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Trial suspension: BAX 802 in CHA With Inhibitors (clinicaltrials.gov) - Jan 14, 2020
P3, N=15, Suspended, Sponsor: Baxalta now part of Shire
Sustainability of these new drugs will depend on post-licensing research, cost-effectiveness, and clinical experience. Recruiting --> Suspended
- prednisolone / Generic mfg., Lysteda (tranexamic acid) / Ferring, Obizur (susoctocog alfa) / Takeda, Ipsen
How we treat patients with acquired haemophilia A with recombinant porcine factor VIII (Industry Exhibition/Foyer) - Dec 17, 2019 - Abstract #GTH2020GTH_175;
There was a close correlation between the measured factor VIII Levels and hemostatic efficacy. We recommend an initial dose of 50 U rpFVIII/kg bodyweight and monitoring of factor VIII levels to trough Levels ofat least 30%.
- ||||| Obizur (susoctocog alfa) / Takeda, Ipsen
Clinical: Better late than never #ASH19 post. The amazing @ElbCarolyne’s work showing that 56% of patients with acquired hemophilia had cross-reacting anti-Obizur inhibitors (higher than what was reported in the RCT). Photo credit @tsengeric. @HinaRChaudhry (Twitter) - Dec 11, 2019
- ||||| Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical: The incredible Dr. @sholzberg higlights an exciting abstract (Sat @ 5:30pm) on impact of cross-reactive anti-recombinant porcine #FVIII antibodies on post-infusion FVIII activity #obizur #AcquiredHemophilia #hemophilia #ASH2019 @wearecare #CAREatASH (Twitter) - Dec 6, 2019
- | Rituxan (rituximab) / Roche, Biogen
Journal: Acquired Hemophilia A Presenting as Intramuscular Hematoma. (Pubmed Central) - Sep 26, 2019
The diagnosis was established based on the coagulation profile along with factor VIII levels, mixing studies, and inhibitor levels. The patient received multiple lines of therapy including steroids, factor VIIa, Obizur (porcine-derived recombinant factor VIII), followed by multiple cycles of chemotherapy including cyclophosphamide and rituximab.
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Trial completion: Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A (clinicaltrials.gov) - Jul 18, 2019
P=N/A, N=53, Completed, Sponsor: Baxalta now part of Shire
The patient received multiple lines of therapy including steroids, factor VIIa, Obizur (porcine-derived recombinant factor VIII), followed by multiple cycles of chemotherapy including cyclophosphamide and rituximab. Active, not recruiting --> Completed
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Journal: The ORC ubiquitin ligase OBI1 promotes DNA replication origin firing. (Pubmed Central) - Jun 25, 2019
Importantly, expression of non-ubiquitylable ORC3/5 mutants impairs origin firing, demonstrating their relevance as OBI1 substrates for origin firing. Our results identify a ubiquitin signalling pathway involved in origin activation and provide a candidate protein for selecting the origins to be fired.
- |||| Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical: The amazing @ElbCarolyne presenting her work at the #AHCDCAGM2019 —> found a prevalence of 58% baseline cross reacting anti-porcine neutralizing Abs that affected Obizur PK. This is much higher than previously published and argues for an Obizur Bethesda testing. (Twitter) - May 25, 2019
- || Obizur (susoctocog alfa) / Takeda, Ipsen
Enrollment closed, Enrollment change: Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A (clinicaltrials.gov) - May 2, 2019
P=N/A, N=60, Active, not recruiting, Sponsor: Baxalta now part of Shire
Our results identify a ubiquitin signalling pathway involved in origin activation and provide a candidate protein for selecting the origins to be fired. Recruiting --> Active, not recruiting | N=40 --> 60
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Trial completion date, Trial primary completion date: BAX 802 in CHA With Inhibitors (clinicaltrials.gov) - Apr 8, 2019
P3, N=15, Recruiting, Sponsor: Baxalta now part of Shire
Recruiting --> Active, not recruiting | N=40 --> 60 Trial completion date: Mar 2019 --> Apr 2021 | Trial primary completion date: Feb 2019 --> Apr 2021
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Observational data, Trial completion date, Trial primary completion date: Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice (clinicaltrials.gov) - Nov 27, 2018
P=N/A, N=50, Recruiting, Sponsor: Baxalta now part of Shire
Trial completion date: Mar 2019 --> Apr 2021 | Trial primary completion date: Feb 2019 --> Apr 2021 Trial completion date: Sep 2021 --> May 2021 | Trial primary completion date: Sep 2021 --> May 2021
- | Obizur (susoctocog alfa) / Takeda, Ipsen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open: A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenstr (clinicaltrials.gov) - Oct 1, 2018
P2, N=30, Recruiting, Sponsor: Polish Myeloma Consortium
Trial completion date: Sep 2021 --> May 2021 | Trial primary completion date: Sep 2021 --> May 2021 Not yet recruiting --> Recruiting
- | Obizur (susoctocog alfa) / Takeda, Ipsen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
New P2 trial: A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenstr (clinicaltrials.gov) - Sep 19, 2018
P2, N=30, Not yet recruiting, Sponsor: Polish Myeloma Consortium
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Trial initiation date: BAX 802 in CHA With Inhibitors (clinicaltrials.gov) - Aug 25, 2018
P3, N=15, Recruiting, Sponsor: Baxalta now part of Shire
Not yet recruiting --> Recruiting Initiation date: Dec 2016 --> May 2017
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Trial completion date, Trial primary completion date: BAX 802 in CHA With Inhibitors (clinicaltrials.gov) - Jul 13, 2018
P3, N=12, Recruiting, Sponsor: Baxalta now part of Shire
Initiation date: Dec 2016 --> May 2017 Trial completion date: Jun 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Feb 2019
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Phase classification, Enrollment change: Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A (clinicaltrials.gov) - Mar 26, 2018
P, N=40, Recruiting, Sponsor: Baxalta now part of Shire
Trial completion date: Jun 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Feb 2019 Phase classification: P=N/A --> P | N=60 --> 40
- | Obizur (susoctocog alfa) / Takeda, Ipsen
P4 data, Trial primary completion date: Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A (clinicaltrials.gov) - Nov 7, 2017
P=N/A, N=60, Recruiting, Sponsor: Baxalta now part of Shire
Phase classification: P=N/A --> P | N=60 --> 40 Trial primary completion date: Nov 2019 --> Aug 2019
- Obizur (susoctocog alfa) / Takeda, Ipsen
New trial, Observational data: Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice (clinicaltrials.gov) - Jun 27, 2017
P=N/A, N=50, Recruiting, Sponsor: Baxalta US Inc.
- | Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Trial initiation date, Trial primary completion date: BAX 802 in CHA With Inhibitors (clinicaltrials.gov) - Apr 20, 2017
P3, N=15, Recruiting, Sponsor: Baxalta US Inc.
Trial primary completion date: Nov 2019 --> Aug 2019 Initiation date: Jul 2016 --> Dec 2016 | Trial primary completion date: Oct 2017 --> May 2018
- ||| Obizur (susoctocog alfa) / Takeda, Ipsen
New P3 trial, Preclinical: BAX 802 in CHA With Inhibitors (clinicaltrials.gov) - Sep 12, 2016
P3, N=15, Recruiting, Sponsor: Baxalta US Inc.
- ||| Obizur (susoctocog alfa) / Takeda, Ipsen
Enrollment open, P4 data: Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A (clinicaltrials.gov) - Feb 9, 2016
P=N/A, N=60, Recruiting, Sponsor: Baxalta US Inc.
Initiation date: Jul 2016 --> Dec 2016 | Trial primary completion date: Oct 2017 --> May 2018 Not yet recruiting --> Recruiting
- ||| Obizur (susoctocog alfa) / Takeda, Ipsen
New trial, P4 data: Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A (clinicaltrials.gov) - Nov 21, 2015
P=N/A, N=60, Not yet recruiting, Sponsor: Baxalta US Inc.
- || Obizur (susoctocog alfa) / Takeda, Ipsen
Trial completion, Preclinical: Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A (clinicaltrials.gov) - Feb 27, 2014
P2/3, N=25, Completed, Sponsor: Baxter Healthcare Corporation
Not yet recruiting --> Recruiting Recruiting --> Completed
- Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Trial termination: Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A (clinicaltrials.gov) - Sep 26, 2013
P3, N=1, Terminated, Sponsor: Baxter Healthcare Corporation
Recruiting --> Completed Active, not recruiting --> Terminated
- Obizur (susoctocog alfa) / Takeda, Ipsen
Preclinical, Enrollment change: Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A (clinicaltrials.gov) - Sep 26, 2013
P3, N=1, Terminated, Sponsor: Baxter Healthcare Corporation
Active, not recruiting --> Terminated N=28 --> 1
- Obizur (susoctocog alfa) / Takeda, Ipsen
New P3 trial, Preclinical: Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A (clinicaltrials.gov) - Sep 13, 2011
P3, N=1, Terminated, Sponsor: Baxter Healthcare Corporation