RECRUITINGPhase 3INTERVENTIONAL
Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- • 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).
Who Should NOT Join This Trial:
- • 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
Recombinant single-chain factor VIII (rVIII-SingleChain)
Lyophilized powder for solution for intravenous injection
Locations (20)
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