Last reviewed 2026-04-23 · How we verify

rVIII-SingleChain

rVIII-SingleChain is a recombinant single-chain factor VIII that replaces deficient clotting factor VIII to restore hemostasis in hemophilia A patients.

rVIII-SingleChain is a recombinant single-chain factor VIII that replaces deficient clotting factor VIII to restore hemostasis in hemophilia A patients. Used for Hemophilia A (treatment and prophylaxis of bleeding episodes).

At a glance

Mechanism of action

This is a genetically engineered factor VIII molecule designed as a single polypeptide chain (rather than the natural two-chain structure) to improve stability and potentially reduce immunogenicity. It functions as a cofactor in the intrinsic coagulation pathway, enabling thrombin generation and clot formation in patients with factor VIII deficiency.

Approved indications

• Hemophilia A (treatment and prophylaxis of bleeding episodes)

Common side effects

• Inhibitor development (factor VIII antibodies)
• Injection site reactions
• Headache
• Hypersensitivity reactions

Key clinical trials

• Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products (PHASE3)
• An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A (PHASE3)
• Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A (PHASE3)
• An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A (PHASE2, PHASE3)

Primary sources

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