New clotting factor shows promise for hemophilia a bleeds
NCT ID NCT06297655
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests a lab-made clotting factor VIII in 60 people with severe hemophilia A. The treatment is given on-demand for new bleeding episodes or before surgery. The goal is to see if it safely and effectively stops bleeding and supports surgical recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human coagulation factor VIII
- What this could lead to
- If successful, this could provide a safe and effective on-demand treatment option for bleeding episodes and surgical support in severe hemophilia A.
- What could go wrong
- This is a single-arm, open-label trial with only 60 participants, so results may not be generalizable. The treatment is not a cure and requires ongoing use.
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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60 people
The number who actually took part.
- Started
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Nov 2024
- Expected to finish
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Jul 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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12 to 65 years
- Sex
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Anyone
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The subjects voluntarily joined this study, signed an informed consent form, and had good compliance; * Age (calculated from the date of signing the informed consent form): ≥12 years and ≤65 years; * Severe hemophilia A (coagulation factor VIII activity\<1%), with exposure days (ED) of no less than 150 days prior to factor VIII (recombinant coagulation factor VIII or plasma derived coagulation factor VIII) treatment; Surgical patients need to have undergone at least 2 surgeries (including major surgeries) and plan to undergo elective surgery at the same time; * The subjects must be HIV negative or have a viral load of \< 200 particles/μ, HIV positive patients with l or \< 400000 copies/ml. * At baseline, no inhibitors were detected, and there was no history of Factor VIII inhibitor antibody formation (Bethesda method detection \< 0.6 BU/ml, test result record required); * Subjects of childbearing age who agree to take effective contraceptive measures throughout the entire trial period and continue until 28 days after the last medication. Exclusion Criteria: * Known congenital or acquired hemorrhagic diseases other than hemophilia A; * The subjects have used or planned to receive immunosuppressive treatments such as prednisone, cyclophosphamide, and cyclosporine in the week prior to enrollment, and are allowed to use inhaled or topical corticosteroids; * Those who are known or suspected to have hypersensitivity reactions to the investigational drug, including human embryonic kidney cell protein; * Significant liver and kidney dysfunction, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 5 upper limit of normal (ULN), and serum creatinine \>1.5 ULN; * Hemoglobin \< 60 g/L; * Expected to receive other drugs for the treatment of hemophilia A within 72 hours before the first administration (such as recombinant factor VIII, blood derived factor VIII, desmopressin, cryoprecipitate, plasma, etc.), or those who have used long-acting hemophilia A drugs for less than 5 half-lives before the first administration; * Used within 14 days before the first administration or planned to use anticoagulants or antiplatelet drugs for treatment during clinical trials; * Within 6 months prior to the first administration, use of Emicizumab; * Serious cardiovascular and cerebrovascular diseases occurring within 6 months prior to the first administration, including but not limited to cerebral hemorrhage, cerebral infarction, unstable angina, malignant arrhythmia, acute myocardial infarction, congestive heart failure (New York Heart Association cardiac function classification ≥ III), and hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure 100 mmHg) that is poorly controlled despite treatment with one or more antihypertensive drugs; * Participated in clinical trials of other drugs within 30 days prior to screening, or last used investigational drug with less than 5 half-lives; * Alcohol abuse, drug abuse, mental disorders, and intellectual disabilities.
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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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Anhui Provincial Hospital
Hefei, Anhui, 230002, China
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Fuyang Hospital Affiliated to Anhui Medical University
Fuyang, Anhui, 236000, China
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Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
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Henan Tumor Hospital
Zhengzhou, Henan, 450003, China
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Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
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Nanjing Drug Tower Hospital
Nanjing, Jiangsu, 210008, China
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
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The First Hospital of Lanzhou University
Lanzhou, Gansu, 730013, China
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
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The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650106, China
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Xiangya Hospital Central South University
Changsha, Hunan, 410008, 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
- Can a newer clotting factor keep its effectiveness in hemophilia a?
- Can a new injection tame hemophilia a bleeding?
- 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?