Active — Not RecruitingPhase 3

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

China60 participantsStarted 2025-01-09

Plain-language summary

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%).

Who can participate

Age range0 Days – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incremental Recovery (IR) of rVIII-SingleChain

Timeframe: Before, and at 30 minutes after the end of, rVIII-SingleChain administration on Day 1

Maximum Concentration (Cmax) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Area Under the Plasma Concentration Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUC0-inf) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Half-life (t1/2) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Clearance (Cl) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Trial details

NCT IDNCT06738485

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-26

View on ClinicalTrials.gov More Congenital Hemophilia A trials

Plain-language summary

Who can participate

Age range0 Days – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incremental Recovery (IR) of rVIII-SingleChain

Timeframe: Before, and at 30 minutes after the end of, rVIII-SingleChain administration on Day 1

Maximum Concentration (Cmax) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Area Under the Plasma Concentration Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUC0-inf) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Half-life (t1/2) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1

Clearance (Cl) of rVIII-SingleChain

Timeframe: Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1