Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products

CSL Behring

Status and phase

Enrolling

Phase 3

Conditions

Congenital Hemophilia A

Treatments

Biological: Recombinant single-chain factor VIII (rVIII-SingleChain)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06738485

CSL627_3003

2023-001026-34 (EudraCT Number)

Details and patient eligibility

About

For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than [<] 1%).

Enrollment

60 estimated patients

Sex

Male

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

• Male Chinese participants <= 65 years of age.
• Participants with severe hemophilia A (FVIII activity < 1%).
• Participants who have received FVIII products for >= 150 EDs (>= 6 years of age) or >= 50 EDs (< 6 years of age).

Exclusion criteria

• Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
• Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
• Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
• Receiving any cryoprecipitate, whole blood, or plasma within 30 days before administration of rVIII-SingleChain.
• Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the participant's participation in the study.