Congenital Hemophilia A

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

NCT06738485 | PHASE 3 | INTERVENTIONAL

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%).

0 Sites

60 Participants

NOT YET RECRUITING

to 65 Years

If interested, contact clinicaltrials@cslbehring.com or +1 610-878-4697 for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

SUBMIT

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov