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8 Trials |
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8 Trials |  |
273 News |  |
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- |||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Trial completion date, Trial primary completion date: XTEND-ed: Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A (clinicaltrials.gov) - Oct 31, 2021
P3, N=262, Recruiting, Sponsor: Bioverativ, a Sanofi company
Trial completion date: Nov 2025 --> Feb 2026 | Trial primary completion date: Nov 2025 --> Feb 2026
- || Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Enrollment closed: Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (clinicaltrials.gov) - Oct 31, 2021
P1, N=13, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Nov 2025 --> Feb 2026 | Trial primary completion date: Nov 2025 --> Feb 2026 Recruiting --> Active, not recruiting
- efanesoctocog alfa (BIVV001) / SOBI, Sanofi
Efanesoctocog alfa (BIVV001): a new Class of Factor Replacement Therapy () - Oct 24, 2021 - Abstract #BIC2021BIC_110;
Recruiting --> Active, not recruiting Sponsored by Sobi; Sponsored by Sanofi Genzyme
- efanesoctocog alfa (BIVV001) / SOBI, Sanofi
Efanesoctocog alfa (BIVV001): Exploring Normalised Haemostasis in Haemophilia () - Oct 24, 2021 - Abstract #BIC2021BIC_107;
Sponsored by Sobi; Sponsored by Sanofi Genzyme Sponsored by Sobi; Sponsored by Sanofi Genzyme
- | Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
Trial primary completion date: To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) (clinicaltrials.gov) - Oct 6, 2021
P1, N=9, Recruiting, Sponsor: Bioverativ, a Sanofi company
Sponsored by Sobi; Sponsored by Sanofi Genzyme Trial primary completion date: Aug 2021 --> Nov 2021
- || Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
New P1 trial: Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (clinicaltrials.gov) - Sep 12, 2021
P1, N=12, Recruiting, Sponsor: Sanofi
- |||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Enrollment closed: XTEND-1: A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A (clinicaltrials.gov) - Aug 27, 2021
P3, N=159, Active, not recruiting, Sponsor: Bioverativ, a Sanofi company
Trial primary completion date: Aug 2021 --> Nov 2021 Recruiting --> Active, not recruiting
- || Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
Enrollment open: To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) (clinicaltrials.gov) - May 20, 2021
P1, N=9, Recruiting, Sponsor: Bioverativ, a Sanofi company
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
New P1 trial: To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) (clinicaltrials.gov) - Feb 25, 2021
P1, N=9, Not yet recruiting, Sponsor: Bioverativ, a Sanofi company
- |||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Enrollment open: XTEND-Kids: Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (clinicaltrials.gov) - Feb 20, 2021
P3, N=65, Recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
New P3 trial: XTEND-Kids: Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (clinicaltrials.gov) - Feb 18, 2021
P3, N=65, Not yet recruiting, Sponsor: Sanofi
- |||||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Enrollment open: XTEND-ed: Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A (clinicaltrials.gov) - Feb 8, 2021
P3, N=262, Recruiting, Sponsor: Bioverativ, a Sanofi company
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- BIVV001 / SOBI, Sanofi
[VIRTUAL] A PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK) MODEL TO CHARACTERIZE BIVV001 ACTIVITY, A NEW CLASS OF FACTOR VIII (FVIII) WITH HIGH SUSTAINED FACTOR ACTIVITY () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_34;
Not yet recruiting --> Recruiting We successfully developed a PBPK model that accurately predicts the high sustained FVIII activity levels observed with BIVV001 weekly dosing in adults with severe hemophilia A. Thus, PBPK model framework can be a useful tool in the development of FVIII replacement therapies for hemophilia A.
- | BIVV001 / SOBI, Sanofi
Journal: Developing BIVV001, a new class of factor VIII replacement for hemophilia A that is von Willebrand factor-independent. (Pubmed Central) - Jan 1, 2021
BIVV001 is the first rFVIII with the potential to significantly change the treatment paradigm for severe hemophilia A by providing optimal protection against all bleed types and less frequent dosing. Protein engineering methods described in the paper can also be applied to other complex proteins.
- |||| BIVV001 / SOBI, Sanofi
P3 data: XTEND-1 - BIVV001 in Phase 3 trials is what we should be waiting for in #hemophilia. Once weekly dosing of FVIII intravenously. #ASH20 (Twitter) - Dec 8, 2020
- |||||||||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
New P3 trial: XTEND-ed: Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A (clinicaltrials.gov) - Nov 24, 2020
P3, N=262, Not yet recruiting, Sponsor: Bioverativ, a Sanofi company
- BIVV001 / SOBI, Sanofi
[VIRTUAL] A Physiologically Based Pharmacokinetic (PBPK) Model for Adults to Characterize BIVV001 Activity, a New Class of Factor VIII (FVIII) with High Sustained Factor Activity () - Nov 5, 2020 - Abstract #ASH2020ASH_4864;
The predicted inter-subject variability was lower than that for the observed data, which is likely due to the inability to include coefficients of variation for all parameters in the current Simcyp biologics module. Conclusions We have developed a PBPK model that accurately predicts the high sustained FVIII activity levels observed with BIVV001 exposure in adults with severe hemophilia A. The PBPK model framework can be a useful tool in the development of FVIII replacement therapies for hemophilia A.
- BIVV001 / SOBI, Sanofi
[VIRTUAL] Evaluating BIVV001, a New Class of Factor VIII Replacement Therapy: A Phase 3 Study (XTEND-1) Design (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1822;
P3
Intra-patient ABR comparison of BIVV001 weekly prophylaxis treatment to historical prophylaxis will be performed. Conclusions XTEND-1 will investigate the efficacy, safety, and pharmacokinetics of 50 IU/kg once-weekly prophylactic dosing of BIVV001, a new class of FVIII replacement with high sustained FVIII activity, in severe hemophilia A. The study has initiated and is currently recruiting.
- | efanesoctocog alfa (BIVV001) / SOBI, Sanofi
Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A. (Pubmed Central) - Oct 9, 2020
P1/2
No safety concerns were reported during the 28-day period after administration. (Funded by Sanofi and Sobi; ClinicalTrials.gov number, NCT03205163.).
- ||| BIVV001 / SOBI, Sanofi
Original Article: BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A (Twitter) - Sep 15, 2020
- |||| BIVV001 / SOBI, Sanofi
BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A | NEJM https://t.co/CODyGWn5P6 (Twitter) - Sep 9, 2020
- ||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Trial completion date, Trial primary completion date: XTEND-1: A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A (clinicaltrials.gov) - Jul 16, 2020
P3, N=150, Recruiting, Sponsor: Bioverativ, a Sanofi company
(Funded by Sanofi and Sobi; ClinicalTrials.gov number, NCT03205163.). Trial completion date: May 2021 --> Oct 2021 | Trial primary completion date: May 2021 --> Oct 2021
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, BIVV001 / SOBI, Sanofi
[VIRTUAL] Population Pharmacokinetic (PK) Analysis of BIVV001 (Rfviiifc-VWF-XTEN), a New Class of Factor VIII (FVIII) Replacement (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_923;
P1/2
Trial completion date: May 2021 --> Oct 2021 | Trial primary completion date: May 2021 --> Oct 2021 Population PK analyses provided comprehensive quantitative characterization of BIVV001 activity-time profiles in adults with severe hemophilia A. Population PK modeling predicts high sustained FVIII activity in the normal to near-normal range for the first 3-4 days post dose to ~10% for one week after 50 IU/kg BIVV001.
- BIVV001 / SOBI, Sanofi
Results of a phase 1 repeat dose of BIVV001 – A new class of factor VIII replacement therapy () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_314;
FVIII activity levels were sustained and non‐accumulating between doses. BIVV001 prophylaxis may lead to more optimal, extended protection against bleeds for individuals with severe hemophilia A.
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, BIVV001 / SOBI, Sanofi
Milestones Towards Normality: From rFVIIIFc to BIVV001 (King Willem-Alexander Room, World Forum Congress Centre The Hague, the Netherlands) - Jan 27, 2020 - Abstract #EAHAD2020EAHAD_195;
- |||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Enrollment open: XTEND-1: A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A (clinicaltrials.gov) - Jan 18, 2020
P3, N=150, Recruiting, Sponsor: Sanofi
BIVV001 prophylaxis may lead to more optimal, extended protection against bleeds for individuals with severe hemophilia A. Not yet recruiting --> Recruiting
- |||| Eloctate (efraloctocog alfa) / Sanofi, SOBI, BIVV001 / SOBI, Sanofi
Clinical: #ASH19 Saturday highlights: a FVIII-VWF D’D3 complex (BIVV001 = rFVIIIFc-VWF-XTEN) cryo-EM structure by dr. Kevin Knockenhauer explains #hemophilia A and #VWD patient mutations - from @SanofiUS 2/4 (Twitter) - Dec 8, 2019
- |||||||| Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
New P3 trial: XTEND-1: A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A (clinicaltrials.gov) - Nov 14, 2019
P3, N=150, Not yet recruiting, Sponsor: Sanofi
- BIVV001 / SOBI, Sanofi
Phase 1 Repeat Dosing with BIVV001: The First Investigational Factor VIII Product to Break through the Von Willebrand Factor–Imposed Half-Life Ceiling (Valencia A (W415A), Level 4 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4856;
By breaking through the VWF-imposed half-life ceiling, BIVV001 prophylaxis may lead to more optimal, extended protection against bleeds for patients with severe hemophilia A than standard FVIII therapies . These results support the continued development of BIVV001 in a Phase 3 clinical trial program.
- BIVV001 / SOBI, Sanofi
Cryo-EM Structure of BIVV001 Reveals Coagulation Factor VIII-Von Willebrand Factor D’D3 Interaction Mode (W414AB, Level 4 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1396;
The structural basis of type 2N von Willebrand Disease mutations in D’D3 can be readily interpreted . Next steps include solving a FVIII-D’D3 dimer structure at high resolution.
- || BIVV001 / SOBI, Sanofi
Great slide by P Lenting illustrating the ingeniosity of BIVV001 to prolong F8 T 1/2 #ISTH2019 (Twitter) - Jul 5, 2019
- || Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Trial completion: A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A) (clinicaltrials.gov) - Dec 19, 2018
P1/2, N=18, Completed, Sponsor: Bioverativ Therapeutics Inc.
Next steps include solving a FVIII-D’D3 dimer structure at high resolution. Recruiting --> Completed
- | Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
Enrollment open: A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A) (clinicaltrials.gov) - Aug 30, 2017
P1/2, N=18, Recruiting, Sponsor: Bioverativ Therapeutics Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting
- | Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
New P1/2 trial: A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A) (clinicaltrials.gov) - Jul 2, 2017
P1/2, N=18, Not yet recruiting, Sponsor: Bioverativ Therapeutics Inc.