Overview
The human von Willebrand factor (vWF) is a human plasma-derived vWF, an endogenous large multimeric plasma glycoprotein involved in hemostasis. It serves a dual role in hemostasis by mediating platelet adhesion and aggregation at the site of blood vessel injury and stabilizing procoagulant factor VIII (FVIII). Exogenous sources of vWF are used to restore functional levels of vWF in blood disorders associated with deficient or abnormal blood clotting. The human vWF is used to manage and control bleeding episodes in patients with von Willebrand disease and hemophilia A. It was first approved by the FDA in 2015. As vWF is normally present in the blood as a stable complex with coagulation factor III, therapeutic vWF products are also available as a combination product with antihemophilic factor human. A recombinant form of vWF, vonicog alfa, is also available to enhance production and avoid the theoretical risk of pathogen transmission from plasma donors.
Indication
The von Willebrand factor (vWF) is indicated to manage and control bleeding episodes in adults with von Willebrand disease. It is also used for perioperative management of bleeding in these patients. It is also used for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy. In combination with antihemophilic factor human, vWF is also used to manage and control bleeding associated with von Willebrand disease in children and adults, as well as for perioperative management of bleeding in these patients. This combination product is also used for the management and control of bleeding episodes in adolescents and adults with hemophilia A, as well as for routine prophylaxis to reduce the frequency of bleeding episodes.
Associated Conditions
- Bleeding
- Perioperative Blood Loss
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/19 | Not Applicable | Not yet recruiting | |||
2021/07/08 | Phase 3 | Completed | |||
2020/09/21 | Phase 4 | Recruiting | University Hospital, Basel, Switzerland | ||
2019/09/27 | N/A | Active, not recruiting | |||
2019/08/12 | Phase 3 | Completed | |||
2018/08/03 | Phase 2 | UNKNOWN | Tirol Kiniken GmbH | ||
2017/12/18 | Phase 3 | Completed | |||
2017/11/17 | N/A | Terminated | |||
2017/07/02 | Phase 4 | Terminated | |||
2016/11/03 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/12/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ALPHANATE FOR INJECTION 1000 iu/vial | SIN09030P | INJECTION, POWDER, FOR SOLUTION | >400 iu / 1000 iu Factor VIII | 11/28/1996 | |
| ALPHANATE FOR INJECTION 250 iu/vial | SIN09031P | INJECTION, POWDER, FOR SOLUTION | >400 iu / 1000 iu Factor VIII | 11/28/1996 | |
| ALPHANATE FOR INJECTION 500 iu/vial | SIN09032P | INJECTION, POWDER, FOR SOLUTION | >400 iu / 1000 iu Factor VIII | 11/28/1996 | |
| Optivate | SIN13191P | INJECTION, POWDER, FOR SOLUTION | 260 iu/ml | 3/16/2006 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| HUMATE-P | csl behring canada inc | 02261219 | Powder For Solution - Intravenous | 600 UNIT / 5 ML | 12/6/2004 |
| ALPHANATE | 02475626 | Powder For Solution - Intravenous | 2400 UNIT / VIAL | N/A | |
| ALPHANATE | 02475618 | Powder For Solution - Intravenous | 1800 UNIT / VIAL | N/A | |
| ALPHANATE | 02475596 | Powder For Solution - Intravenous | 1200 UNIT / VIAL | N/A | |
| HUMATE-P | csl behring canada inc | 02261235 | Powder For Solution - Intravenous | 2400 UNIT / 15 ML | 12/6/2004 |
| WILATE | octapharma pharmazeutika produktionsges m b h | 02286750 | Powder For Solution - Intravenous | 500 UNIT / 5 ML | 4/29/2008 |
| HUMATE-P | csl behring canada inc | 02261227 | Powder For Solution - Intravenous | 1200 UNIT / 10 ML | 12/6/2004 |
| ALPHANATE | 02475588 | Powder For Solution - Intravenous | 600 UNIT / VIAL | N/A | |
| WILATE | octapharma pharmazeutika produktionsges m b h | 02286769 | Powder For Solution - Intravenous | 1000 UNIT / 10 ML | 4/29/2008 |
| ALPHANATE | 02475561 | Powder For Solution - Intravenous | 300 UNIT / VIAL | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FANHDI 100 UI FVIII/120 UI FVW POR ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 60602 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| HAEMATE P 2400/1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PERFUSION. | Csl Behring S.A. | 56868 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| FANHDI 25 UI FVIII/30 UI FVW POR ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 60601 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| FANHDI 50 UI FVIII/60 UI FVW POR ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 60600 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| HAEMATE P 1200 UI/500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PERFUSION. | Csl Behring S.A. | 56867 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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