Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant von Willebrand factor: recombinant FVIII · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII) | BIOLOGICAL | Single dose, dose escalation, various cohorts |
| Marketed plasma-derived VWF/FVIII concentrate | BIOLOGICAL | Cross-over: recombinant FVIII (rVWF:rFVIII) and marketed plasma-derived VWF/FVIII concentrate |
Inclusion Criteria: * Subject has voluntarily given written informed consent (before conduct of any study-related procedures) * The subject has hereditary type 3 VWD (\<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo \<= 10% and FVIII:C \<20%) * The subject has a medical history of at lea...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Vonvendi, ADVATE |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE2 | ALN-6400 |
| Hemab Therapeutics Holdings, Inc. | COAG | 2 | PHASE1 | HMB-002 |
Recombinant von Willebrand factor: recombinant FVIII is an investigational biologic complex being studied for Von Willebrand Disease, a bleeding disorder. It combines recombinant von Willebrand factor with recombinant factor VIII. Takeda Pharmaceutical Company Limited is developing it, and it has been tested in a Phase 1 pharmacokinetic, safety and tolerability study.
It is being studied for use in Von Willebrand Disease, specifically in patients with Type 3 Von Willebrand Disease in the completed Phase 1 trial. The study evaluated pharmacokinetics, safety and tolerability of the recombinant von Willebrand factor and recombinant factor VIII complex in adults aged 18 years and older.
The complex targets F9, also known as factor IX, and is classified as an exogenous protein therapy. It supplies recombinant von Willebrand factor alongside recombinant factor VIII. The completed Phase 1 study examined how this complex behaved pharmacokinetically in patients with Type 3 Von Willebrand Disease.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of recombinant von Willebrand factor: recombinant FVIII. The company sponsored the completed Phase 1 trial of the complex in Type 3 Von Willebrand Disease.
Recombinant von Willebrand factor: recombinant FVIII is in Phase 1 development and is investigational. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 32 participants and was randomized, active controlled, and conducted without blinding.
The complex has been studied in one completed Phase 1 trial, NCT00816660, titled a pharmacokinetic, safety and tolerability study of recombinant von Willebrand factor and recombinant factor VIII complex in Type 3 Von Willebrand Disease. It enrolled 32 adults across the United States, Austria, Canada, Germany, Italy, and the United Kingdom.
Yes, rVWF:rFVIII is another name for recombinant von Willebrand factor: recombinant FVIII. The abbreviation stands for the recombinant von Willebrand factor and recombinant factor VIII complex. Both names refer to the same investigational product developed by Takeda for Von Willebrand Disease.