Investigating a new treatment for severe hemophilia A in Chinese males
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
This study is testing a new treatment for severe hemophilia A in Chinese men to see if a special factor VIII can help prevent bleeding better than current options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 65 Years |
| Sex | Male |
| Sponsor | CSL Behring Industry-sponsored |
| Locations | 11 sites (Hefei, Anhui and 10 other locations) |
| Trial ID | NCT06738485 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the pharmacokinetics and efficacy of recombinant single-chain factor VIII (rVIII-SingleChain) in male Chinese participants with severe hemophilia A. Participants will receive prophylactic treatment with rVIII-SingleChain 2 to 3 times weekly, and the study will assess both the safety and effectiveness of this treatment approach. The research focuses on individuals who have previously been treated with FVIII products, bridging global clinical data with the Chinese population. The study is designed to provide insights into how this treatment works specifically in this demographic.
Who should consider this trial
Good fit: Ideal candidates are male Chinese participants aged 65 years or younger with severe hemophilia A and a history of FVIII product treatment.
Not a fit: Patients with known hypersensitivity to FVIII products or other coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of severe hemophilia A in Chinese patients.
How similar studies have performed: Other studies have shown promise with similar recombinant factor VIII treatments, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui and 10 other locations
- The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
- Beijing Children's Hospital — Beijing, Beijing, China (Recruiting)
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Recruiting)
- Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
- Liuzhou People's Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
- Hospital of Hematology, Chinese Academy of Medical Sciences — Tianjin, Hebei, China (Recruiting)
- Hunan Provincial Children's Hospital — Changsha, Hunan, China (Recruiting)
- XuZhou Children's Hospital — Xuzhou, Jiangsu, China (Recruiting)
- Quinghai Provincial People's Hospital — Xining, Qinghai, China (Recruiting)
- Qingdao Women and Children's Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Trial Registration Coordinator
- Email: clinicaltrials@cslbehring.com
- Phone: +1-610-878-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.