Study on Safety and Efficacy of the Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company (Safacto) in Comparing with Recombinant Factor VIII of Pfizer Pharmaceutical Company (Xyntha) in Patients with Sever Hemophilia A,Exposing to Factor VIII for More Than 50 Days

Start Date23 Oct 2014

Sponsor / Collaborator-

IRCT2014082018870N1 / CompletedPhase 3IIT

Study on Safety and Efficacy of the Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company (Safacto) in Comparing with Plasma-derived Factor VIII in Patients with Sever Hemophilia A,Exposing to Factor VIII for More Than 50 Days.

Start Date22 Aug 2013

Sponsor / Collaborator-

NCT01405742 / TerminatedPhase 3IIT

R34 Pilot Feasibility Randomized, Noninferiority, Cross-Over Trial of Once-Weekly vs. Thrice-Weekly Prophylaxis With Recombinant Factor VIII in Adults With Severe Hemophilia A

The purpose of this pilot R34 trial is to determine the feasibility of a large single dose Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by thrombin generation. Safety will be measured by inhibitor formation and bleeding events unresponsive to up to two rescue doses.

Start Date01 Jul 2012

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Recombinant factor VIII(Saman Daroo 8)

100 Translational Medicine associated with Recombinant factor VIII(Saman Daroo 8)

100 Patents (Medical) associated with Recombinant factor VIII(Saman Daroo 8)

551

Literatures (Medical) associated with Recombinant factor VIII(Saman Daroo 8)

01 Sep 2024·Drugs in R&D

Damoctocog Alfa Pegol, a PEGylated B-domain Deleted Recombinant Extended Half-life Factor VIII for the Treatment of Hemophilia A: A Product Review

Review

Author: Poulsen, Lone H ; Shah, Anita ; Solms, Alexander ; Ducore, Jonathan ; Simpson, Mindy ; Meijer, Karina ; Lalezari, Shadan ; Kenet, Gili ; Holme, Pål André ; Di Minno, Giovanni ; Reding, Mark T ; Mancuso, Maria Elisa

Damoctocog alfa pegol (BAY 94-9027, Jivi^®), is a site-specifically PEGylated, extended half-life recombinant factor VIII (FVIII) that is approved in several European and non-European countries for on-demand treatment and prophylaxis of bleeding in previously treated patients aged ≥ 12 years with hemophilia A. Reliable measurements can be obtained using most one-stage and chromogenic FVIII assays over a wide concentration range. The efficacy, safety and pharmacokinetics (PK) of damoctocog alfa pegol have been studied extensively in the PROTECT VIII clinical trials, and its long-term safety and effectiveness profile is continuing to build through observational and interventional real-world studies. The PK of damoctocog alfa pegol was shown to be improved as compared with that of sucrose-formulated rFVIII (rFVIII-FS, Kogenate^®), and was also demonstrated to be non-inferior to and, for some variables, more favorable than rFVIII-Fc fusion protein, efmoroctocog alfa (Elocta^®; NCT03364998), rurioctocog alfa pegol (BAX 855, Adynovate^®/Adynovi^®; NCT04015492), and antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM, Advate^®; NCT02483208). Damoctocog alfa pegol was generally well tolerated and none of the patients in any of the clinical trials, including the PROTECT VIII clinical program, HEM-POWR, or ongoing single-center studies, developed FVIII inhibitors. Efficacy for perioperative hemostasis has been demonstrated. Low bleeding rates were achieved across the studies, with twice weekly, every 5-day and every 7-day prophylaxis offering patients ≥ 12 years and their clinicians the chance to tailor treatment to individual needs and lifestyles, while maintaining long-term protection from bleeds and their consequences.

01 Jul 2024·Research and Practice in Thrombosis and Haemostasis

Real-world usage and effectiveness of recombinant factor VIII/factor IX Fc in hemophilia A/B: final data from the 24-month, prospective, noninterventional PREVENT study in Germany

Article

Author: Nüesch, Eveline ; Tiede, Andreas ; Miesbach, Wolfgang ; Langer, Florian ; Oldenburg, Johannes ; Scholz, Ute ; Bidlingmaier, Christoph ; Santagostino, Elena ; Palmborg, Helena ; Heller, Christine

BackgroundReal-world experience with efmoroctocog alfa (a recombinant factor [F]VIII Fc fusion protein [rFVIIIFc]) and eftrenonacog alfa (a recombinant factor IX Fc fusion protein [rFIXFc]) is needed to bridge evidence gaps.ObjectivesTo describe rFVIIIFc/rFIXFc usage and effectiveness over a 24-month prospective period.MethodsPREVENT (NCT03055611), a noninterventional study across 25 German hemophilia treatment centers, enrolled previously treated persons with hemophilia A and B (all ages/severities) on individualized rFVIIIFc/rFIXFc prophylaxis before/at enrollment. Primary endpoints included annualized bleeding rate (ABR), injection frequency (IF), and factor consumption (FC). Additionally, up to 12 months of retrospective FVIII/FIX data were collected. Physician and patient satisfaction, and safety outcomes were also assessed.ResultsOverall, 150 patients received ≥1 rFVIIIFc dose and 47 patients received ≥1 rFIXFc dose, with median prospective follow-up of 20.6 and 21.0 months, respectively. rFVIIIFc/rFIXFc demonstrated low median ABR (0.5/1.7), annualized IF (121.8/52.2 injections/y), and FC (4611.7/2423.9 IU/kg) in line with product labels. Compared with previous FVIII/FIX, there was a 56.0% reduction in ABR for rFVIIIFc (rate ratio, 0.44; 95% CI, 0.31-0.64), with no change for rFIXFc (rate ratio, 0.93; 95% CI, 0.66-1.31); rFVIIIFc/rFIXFc reduced annualized IF (rFVIIIFc, mean difference, -31.7; 95% CI, -40.3 to -23.1; rFIXFc, mean difference, -37.3; 95% CI, -46.9 to -27.8), while FC remained stable (rFVIIIFc, +374.1; 95% CI, +46.8 to +701.3; rFIXFc, +503.9; 95% CI, +95.4 to +912.4). Most physicians and patients were satisfied or highly satisfied with rFVIIIFc/rFIXFc. rFVIIIFc/rFIXFc were well tolerated, with no inhibitor development or treatment-related serious adverse events.ConclusionReal-world PREVENT data complement phase 3 trials and show that individualized rFVIIIFc/rFIXFc prophylaxis provided stable bleed protection with low IF and maintained FC. Compared with previous FVIII, ABR was considerably reduced with rFVIIIFc, with stable annualized FC. For rFIXFc, bleed protection was maintained vs previous FIX while reducing annualized IF.

01 Jul 2024·Journal of Medical Virology

Reconstruction of the historic time course of blood‐borne virus contamination of clotting factor concentrates, 1974–1992

Article

Author: Rajendra, Piya ; Reid, Kaitlin ; Breuer, Judy ; Gates, Shannah ; Golubchik, Tanya ; Irving, William L ; Tarr, Alexander W ; Kean, Kai ; Harvala, Heli ; McClure, C Patrick ; Mayne, Richard ; Simmonds, Peter ; Makris, Michael ; Fu, Michael X

AbstractFactor VIII and IX clotting factor concentrates manufactured from pooled plasma have been identified as potent sources of virus infection in persons with hemophilia (PWHs) in the 1970s and 1980s. To investigate the range and diversity of viruses over this period, we analysed 24 clotting factor concentrates for several blood‐borne viruses. Nucleic acid was extracted from 14 commercially produced clotting factors and 10 from nonremunerated donors, preserved in lyophilized form (expiry dates: 1974–1992). Clotting factors were tested by commercial and in‐house quantitative PCRs for blood‐borne viruses hepatitis A, B, C and E viruses (HAV, HBV, HCV, HEV), HIV‐ types 1/2, parvoviruses B19V and PARV4, and human pegiviruses types 1 and 2 (HPgV‐1,‐2). HCV and HPgV‐1 were the most frequently detected viruses (both 14/24 tested) primarily in commercial clotting factors, with frequently extremely high viral loads in the late 1970s–1985 and a diverse range of HCV genotypes. Detection frequencies sharply declined following introduction of virus inactivation. HIV‐1, HBV, and HAV were less frequently detected (3/24, 1/24, and 1/24 respectively); none were positive for HEV. Contrastingly, B19V and PARV4 were detected throughout the study period, even after introduction of dry heat treatment, consistent with ongoing documented transmission to PWHs into the early 1990s. While hemophilia treatment is now largely based on recombinant factor VIII/IX in the UK and elsewhere, the comprehensive screen of historical plasma‐derived clotting factors reveals extensive exposure of PWHs to blood‐borne viruses throughout 1970s‐early 1990s, and the epidemiological and manufacturing parameters that influenced clotting factor contamination.

100 Deals associated with Recombinant factor VIII(Saman Daroo 8)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 3	-	Saman Daroo 8	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2020	Not Applicable	-	-	Recombinant multimeric von Willebrand factor	mgxfpalcwc(bkhmkjalcb) = okrimtnybz nasspdjpth (fprqtvxkzw )	-	12 Jul 2020
				Recombinant Factor VIII	mgxfpalcwc(bkhmkjalcb) = uvghbrtkje nasspdjpth (fprqtvxkzw )

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