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human VWF/FVIII concentrate
Human VWF/FVIII concentrate replaces clotting factors in the blood to prevent or control bleeding episodes in patients with hemophilia A.
Human VWF/FVIII concentrate replaces clotting factors in the blood to prevent or control bleeding episodes in patients with hemophilia A. Used for Hemophilia A, Surgery in patients with hemophilia A.
At a glance
| Generic name | human VWF/FVIII concentrate |
|---|---|
| Sponsor | Octapharma |
| Drug class | Coagulation factor replacement therapy |
| Target | Factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
This drug works by providing the necessary clotting factors to help the blood to clot properly. It is used to prevent or control bleeding episodes in patients with hemophilia A, a genetic disorder that impairs the body's ability to make blood clots.
Approved indications
- Hemophilia A
- Surgery in patients with hemophilia A
Common side effects
- Headache
- Nausea
- Pain at injection site
Key clinical trials
- Treatment of Hemophilia A Patients With FVIII Inhibitors
- A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD (PHASE3)
- Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease (PHASE4)
- Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients (PHASE4)
- Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (NA)
- Study of Voncento® in Subjects With Von Willebrand Disease (PHASE4)
- Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease (PHASE2, PHASE3)
- Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- human VWF/FVIII concentrate CI brief — competitive landscape report
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