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CSL BehringRecombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products Phase 3 60
Clinical Trial NCT06738485 is designed to study Prevention for Congenital Hemophilia A. It is a Phase 3 interventional study that is recruiting, having started on 9 January 2025, with plans to enroll 60 participants. Led by CSL Behring, it is expected to complete by 26 June 2026. The latest data from ClinicalTrials.gov was last updated on 8 January 2026.
Brief 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%).
Official Title
A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Previously Treated Patients (PTPs) With Hemophilia A
Conditions
Congenital Hemophilia AOther Study IDs
- CSL627_3003
- 2023-001026-34 (EudraCT Number)
NCT ID Number
Start Date (Actual)
2025-01-09
Last Update Posted
2026-01-08
Completion Date (Estimated)
2026-06-26
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalrVIII-SingleChain Participants will receive rVIII-SingleChain as an intravenous (IV) infusion for a minimum of 50 exposure days (EDs). | Recombinant single-chain factor VIII (rVIII-SingleChain) Lyophilized powder for solution for intravenous injection |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incremental Recovery (IR) of rVIII-SingleChain | Before, and at 30 minutes after the end of, rVIII-SingleChain administration on Day 1 | |
Maximum Concentration (Cmax) of rVIII-SingleChain | 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 | 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 | 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 | 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 | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Annualized Spontaneous Bleeding Rate (AsBR) | AsBR for treated bleeding episodes | Up to 29 weeks after rVIII-SingleChain administration |
Number of participants who develop FVIII inhibitors | During routine rVIII-SingleChain prophylaxis dosing, up to 29 weeks after rVIII-SingleChain administration. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to reach maximum concentration (Tmax) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Last Concentration (Clast) of rVIII-SingleChain | Last observed quantifiable plasma concentration | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 |
IR (participants ≥ 12 years of age) of rVIII-SingleChain (Repeat pharmacokinetic [PK]) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
Cmax (participants ≥ 12 years of age) of rVIII-SingleChain (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
AUC0-last of rVIII-SingleChain (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
AUC0-inf of rVIII-SingleChain (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
t1/2 of rVIII-SingleChain (participants ≥ 12 years of age) (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
Cl of rVIII-SingleChain (participants ≥ 12 years of age) (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
Annualized Bleeding Rate (ABR) | Total ABR for treated, untreated, and both treated and untreated bleeding episodes (spontaneous, traumatic, and unknown cause) | Up to 29 weeks after rVIII-SingleChain administration |
Hemostatic Efficacy for Major and Nonmajor Bleeding Episodes | The investigator will rate the efficacy of the rVIII-SingleChain treatment for major and nonmajor bleeding episodes based on a hemostatic efficacy four point rating scale of "excellent, good, moderate or no efficacy". | Up to 29 weeks after rVIII-SingleChain administration |
Consumption of rVIII-SingleChain - number of infusions (doses) | Up to 29 weeks after rVIII-SingleChain administration | |
Consumption of rVIII-SingleChain - IU/kg per participant per month | rVIII-SingleChain consumption (IU/kg) per participant per month, for the weekly regimen, on-demand treatment, and total treatment. | Up to 29 weeks after rVIII-SingleChain administration |
Consumption of rVIII-SingleChain - IU/kg per participant per year | rVIII-SingleChain consumption (IU/kg) per participant per year, for the weekly regimen, on-demand treatment, and total treatment. | Up to 29 weeks after rVIII-SingleChain administration |
Number of bleeding episodes requiring rVIII-SingleChain to achieve hemostasis | Number of bleeding episodes requiring 1, \<= 2, or \> 2 infusions (doses) of rVIII-SingleChain to achieve hemostasis | Up to 29 weeks after rVIII-SingleChain administration |
Percentage of bleeding episodes requiring rVIII-SingleChain to achieve hemostasis | Percentage of bleeding episodes requiring 1, \<= 2, or \> 2 infusions (doses) of rVIII-SingleChain to achieve hemostasis | Up to 29 weeks after rVIII-SingleChain administration |
Number of participants who develop noninhibitory antibodies against rVIII-SingleChain | Before, and up to 29 weeks after, rVIII-SingleChain administration | |
Number of participants who develop antibodies against Chinese hamster ovary host cell protein | Before, and up to 29 weeks after, rVIII-SingleChain administration | |
Number of participants with Treatment-emergent Adverse Events (TEAEs), including related TEAEs, and serious adverse events (SAEs) | Up to 33 weeks after rVIII-SingleChain administration | |
Percentage of participants with TEAEs, including related TEAEs, and serious adverse events (SAEs) | Up to 33 weeks after rVIII-SingleChain administration | |
Number of TEAEs (events) | Up to 33 weeks after rVIII-SingleChain administration |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
0 Days
Eligible Sexes
Male
- • 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).
- • 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.
CSL Behring30 active studies to exploreStudy Central Contact
Contact: Trial Registration Coordinator, +1-610-878-4000, [email protected]
20 Study Locations in 1 Countries
Anhui
The Second Hospital of Anhui Medical University, Hefei, Anhui, 230000, China
Study Coordinator, Contact, +86 18860473785
Recruiting
Beijing Municipality
Beijing Children's Hospital, Beijing, Beijing Municipality, 100045, China
Study Coordinator, Contact, +86 19967242842
Recruiting
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400014, China
Recruiting
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Study Coordinator, Contact, +86-13960923029
Recruiting
Guangdong
Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, 510623, China
Study Coordinator, Contact, +86 14714147022
Recruiting
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 515399, China
Study Coordinator, Contact, +86 13407467308
Recruiting
Guangxi
Liuzhou People's Hospital, Liuchow, Guangxi, 545006, China
Study Coordinator, Contact, + 86 18775236492
Recruiting
Hebei
North China University of Science and Technology Affiliated Hospital, Tangshan, Hebei, 63000, China
Study Coordinator, Contact, +86 13596672024
Recruiting
Hospital of Hematology, Chinese Academy of Medical Sciences, Tianjin, Hebei, 300020, China
Study Coordinator, Contact, +86 15002287107
Recruiting
Henan
Henan children's hospital Zhengzhou children's Hospital, Zhengzhou, Henan, 450053, China
Recruiting
Hunan
Hunan Provincial Children's Hospital, Changsha, Hunan, 410021, China
Study Coordinator, Contact, +86 19138294667
Recruiting
Jiangsu
Nanjing Children's Hospital, Nanjing, Jiangsu, 210008, China
Recruiting
XuZhou Children's Hospital, Xuzhou, Jiangsu, 221006, China
Study Coordinator, Contact, +86 15062104467
Recruiting
Jiangxi
Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, 212028, China
Study Coordinator, Contact, +86 13879403212
Recruiting
Qinghai
Quinghai Provincial People's Hospital, Xining, Qinghai, 81000, China
Study Coordinator, Contact, +86 18795981099
Recruiting
Shandong
Jinan Central Hospital, Jinan, Shandong, 250013, China
Recruiting
Qingdao Women and Children's Hospital, Qingdao, Shandong, 266071, China
Study Coordinator, Contact, +86 13156850390
Recruiting
Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Ruijin Hospital, Shanghai, Shanghai Municipality, 200020, China
Study Coordinator, Contact, +86 17621778635
Recruiting
Yunan
The second affiliated hospital of Kunming Medical University, Kunming, Yunan, 650011, China
Study Coordinator, Contact, +86 18287102704
Recruiting
Zhejiang
The Children's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310005, China
Study Coordinator, Contact, +86 17621778635
Recruiting