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Human cl rhFVIII
Human cl rhFVIII is a recombinant human Factor VIII that replaces deficient or dysfunctional clotting factor VIII to restore blood coagulation in hemophilia A patients.
Human cl rhFVIII is a recombinant human Factor VIII that replaces deficient or dysfunctional clotting factor VIII to restore blood coagulation in hemophilia A patients. Used for Hemophilia A (congenital Factor VIII deficiency).
At a glance
| Generic name | Human cl rhFVIII |
|---|---|
| Sponsor | Octapharma |
| Drug class | Recombinant clotting factor |
| Target | Factor VIII (coagulation factor VIII) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Factor VIII is a critical cofactor in the intrinsic coagulation pathway that works with von Willebrand factor to activate Factor X. In hemophilia A, Factor VIII is absent or defective, leading to impaired thrombin generation and bleeding. Recombinant Factor VIII replacement therapy restores normal coagulation cascade function and hemostatic capacity.
Approved indications
- Hemophilia A (congenital Factor VIII deficiency)
Common side effects
- Inhibitor development (anti-Factor VIII antibodies)
- Injection site reactions
- Headache
- Fever
Key clinical trials
- Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (PHASE1, PHASE2)
- Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
- Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (PHASE3)
- Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (PHASE3)
- Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (PHASE3)
- Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs) (PHASE3)
- Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A (PHASE2)
- Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A (PHASE3)
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 cl rhFVIII CI brief — competitive landscape report
- Human cl rhFVIII updates RSS · CI watch RSS
- Octapharma portfolio CI