New hope for hemophilia a: experimental clotting factor shows promise in chinese trial
NCT ID NCT06738485
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing a new form of factor VIII (rVIII-SingleChain) in 60 Chinese men with severe hemophilia A. The goal is to see how well the drug works to prevent and treat bleeding episodes when given 2-3 times per week. Researchers will also check how the body processes the drug and monitor for side effects like inhibitor development.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant single-chain factor VIII (rVIII-SingleChain)
- What this could lead to
- If successful, this could provide a new, effective treatment option to control bleeding episodes in Chinese patients with severe hemophilia A.
- What could go wrong
- This is a relatively small, open-label study (60 participants) focused on pharmacokinetics and safety. The treatment requires regular infusions and does not cure hemophilia; patients will still need lifelong management.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 days to 65 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Children's Hospital
Beijing, Beijing Municipality, 100045, China
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Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, China
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Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
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Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623, China
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Henan children's hospital Zhengzhou children's Hospital
Zhengzhou, Henan, 450053, China
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Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Hebei, 300020, China
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Hunan Provincial Children's Hospital
Changsha, Hunan, 410021, China
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Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 212028, China
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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Liuzhou People's Hospital
Liuzhou, Guangxi, 545006, China
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 515399, China
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Nanjing Children's Hospital
Nanjing, Jiangsu, 210008, China
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North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 63000, China
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Qingdao Women and Children's Hospital
Qingdao, Shandong, 266071, China
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Quinghai Provincial People's Hospital
Xining, Qinghai, 81000, China
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Shanghai Jiaotong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, 200020, China
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The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310005, China
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The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
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The second affiliated hospital of Kunming Medical University
Kunming, Yunan, 650011, China
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XuZhou Children's Hospital
Xuzhou, Jiangsu, 221006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Weekly shot cut the burden of hemophilia a?
- Once-a-Week shot aims to stop bleeds in severe hemophilia a
- A Once-a-Week shot could transform hemophilia Care—Even for those with inhibitors
- Can a new clotting factor offer better bleed protection for severe hemophilia?
- New clotting factor aims to cut bleeding episodes in severe hemophilia a
- New clotting factor aims to stop bleeding in severe hemophilia a