Delving into the Latest Updates on Antihemophilic factor/von Willebrand factor complex(Grifols SA) with Synapse

This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate.
The study consists of 2 phases:
An ITI Treatment Phase in which all eligible participants will receive ITI treatment with alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, participants will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a participants has achieved partial immune tolerance, the participants will enter a 12-month Prophylactic Phase.
A 12-month Prophylactic Phase for all participants who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of alphanate. Due to limited enrollment, this study was early terminated.

Start Date03 Jan 2018

Sponsor / Collaborator

Grifols Therapeutics, Inc.

[+1]

CTRI/2017/04/008336 / Active, not recruitingPhase 2

A Multicenter, Phase 2 Open-Label, Single-Arm, Prospective, InterventionalStudy of Plasma-Derived Factor VIII/VWF (AlphanateÃ?Â®) in Immune Tolerance InductionTherapy in Subjects with Congenital Hemophilia A and Inhibitors - Nil

Start Date02 May 2017

Sponsor / Collaborator-

EUCTR2012-003450-92-ES / Unknown statusNot Applicable

EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WITH VON WILLEBRAND DISEASE - Study of Fanhdi® in pediatric patients with VWD

Start Date23 Nov 2013

Sponsor / Collaborator

Instituto Grifols SA

100 Clinical Results associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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100 Translational Medicine associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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100 Patents (Medical) associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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80

Literatures (Medical) associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

01 Jan 2024·Clinical and Applied Thrombosis/Hemostasis

Real-World Efficacy and Safety of Plasma-Derived Von Willebrand Factor-Containing Factor VIII Concentrates in Patients With Von Willebrand Disease in Italy

Article

Author: Pieri, Lisa ; Santoro, Cristina ; Borchiellini, Alessandra ; Barillari, Giovanni ; Santoro, Rita Carlotta ; Mir, Roser ; Federici, Augusto B. ; Tosetto, Alberto ; Zanon, Ezio ; Santi, Roberto Mario ; De Cristofaro, Raimondo ; Mairal, Esther

Plasma-derived von Willebrand factor-containing factor VIII concentrates (pd-VWF/FVIII-C) are the mainstay of treatment in von Willebrand disease (VWD). Real-world data on efficacy and safety of these pd-VWF/FVIII-C are required. To retrospectively evaluate the efficacy and safety of pd-VWF/FVIII-C (Fanhdi® and Alphanate®, Grifols) in clinical practice in Italy. A multicentric, observational, retrospective study at 10 Italian centers was conducted. Eligible patients diagnosed with inherited VWD (ISTH criteria) were treated with either Fanhdi® or Alphanate® for bleeding episodes, prevention of surgical bleeding and secondary long-term prophylaxis (SLTP) according to clinical practice with medical records collected from January 2007 to December 2019. Efficacy/safety of pd-VWF/FVIII-C was assessed according to FDA-agreed objective criteria following regulatory procedures. Fifty-seven patients (M/F: 21/36) were enrolled in the study with the following VWD types: VWD1 (n = 29, 52%), VWD2A (n = 10, 18%), VWD2B (n = 7, 12%), VWD2M (n = 2, 4%), VWD2N (n = 1, 2%), VWD2 unclassified (n = 1, 2%), and VWD3 (n = 7, 12%). These pd-VWF/FVIII-C were used to manage 58 bleeding episodes (n = 24 patients), 100 surgeries (n = 47 patients), and 7 SLTP (n = 6 patients). Global clinical efficacy with these pd-VWF/FVIII-C was reported to be excellent/good in 85% of bleeding episodes, 98% of surgeries, and 100% of SLTP. As far as safety, no adverse-drug-related episodes, immunogenic or thrombotic events were reported. This study confirmed that Fanhdi® and Alphanate® were effective and safe in the management of bleeding episodes, the prevention of bleeding during surgeries and for SLTP in Italian patients with inherited VWD.

13 Jun 2023·Cureus

Anesthetic Management Including Postoperative Regional Anesthesia in a Young Adult Patient With Von Willebrand Disease and Osteogenesis Imperfecta

Author: Crespo, Maria J ; Torres-Pérez, Hector ; Rosa-Carrasquillo, Cristian ; Rivera-Pérez, Dennys ; Reyes-Sullivan, Allan J

There are no established guidelines regarding anesthesia with a peripheral nerve block (PNB) in the young adult population with von Willebrand disease (vWD) type I. We present a case of a successful PNB outcome in a 20-year-old male patient with vWD type I, osteogenesis imperfecta (OI), and rheumatoid arthritis (RA) who underwent an intramedullary nailing surgery after suffering a left distal femur fracture secondary to a sports injury. Before the procedure, the patient was treated with HUMATE-P® [antihemophilic factor and von Willebrand factor (human)], ALPHANATE^® (antihemophilic factor/von Willebrand factor complex), and aminocaproic acid for hematologic control. Left femoral and popliteal nerve blocks were performed for postoperative pain control. The patient was discharged home uneventfully three days after the surgery. In this case, PNB proved to be a safe and effective alternative in the management of a vWD type I young adult patient with comorbidities. Given the lack of established guidelines, a multidisciplinary team should be involved in the pre and perioperative management of these patients due to the risk of delayed bleeding.

01 Jan 2022·Haemophilia

Efficacy and safety evaluation of Fanhdi^®, a plasma‐derived factor VIII/ von Willebrand factor concentrate, in Von Willebrand's disease patients undergoing surgery or invasive procedures: A prospective clinical study

Letter

Author: Jimenez‐Yuste, Victor ; Alvarez‐Roman, Maria Teresa ; Grifols, Carlota ; Páez, Antonio ; Torres, Mireia ; Haya, Saturnino ; Núñez, Laura ; Martin‐Salces, Monica ; Mairal, Esther ; Federici, Augusto B.

100 Deals associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Antihemophilic factor/von Willebrand factor complex(Grifols SA)	B02BD06	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hemophilia A	US	Alpha Therapeutic Corp.	17 Dec 1998
Factor 8 Deficiency, Acquired	US	Grifols Biologicals, Inc.	15 Aug 1978
Von Willebrand Diseases	US	-	15 Aug 1978

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 1	ES	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 1	CA	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 1	ES	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 1	IT	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 1	RU	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 1	IT	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 1	IN	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 1	RU	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 1	CA	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 1	IN	Grifols Therapeutics, Inc.	03 Jan 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03095287 (CTgov)	Phase 2	Hemophilia A	2	Alphanate	ydylpcgsnd(rhuayyoxtq) = flwckclefl jnuktytwfm (dwakcmaowo, ebxwhwajdq - erireidbwx) View more	-	23 Nov 2021
ISTH2020	Not Applicable	Von Willebrand Diseases	-	Fanhdi®	satlyqdcjn(sfqlpqnqgx) = sxycbpesip gmsjfdtvph (affcpqipdd ) View more	Positive	12 Jul 2020