Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products
NCT ID: NCT06738485
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2025-01-09
2026-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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rVIII-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
Interventions
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Recombinant single-chain factor VIII (rVIII-SingleChain)
Lyophilized powder for solution for intravenous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* • 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 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.
0 Days
65 Years
MALE
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Children's Hospital
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Hebei, China
Henan children's hospital Zhengzhou children's Hospital
Zhengzhou, Henan, China
Hunan Provincial Children's Hospital
Changsha, Hunan, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
XuZhou Children's Hospital
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Quinghai Provincial People's Hospital
Xining, Qinghai, China
Jinan Central Hospital
Jinan, Shandong, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
Shanghai Jiaotong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China
The second affiliated hospital of Kunming Medical University
Kunming, Yunan, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Other Identifiers
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2023-001026-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL627_3003
Identifier Type: -
Identifier Source: org_study_id
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