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New clotting factor shows promise for hemophilia a bleeds

NCT ID NCT06297655

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

12 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Anhui Provincial Hospital

    Hefei, Anhui, 230002, China

  • Fuyang Hospital Affiliated to Anhui Medical University

    Fuyang, Anhui, 236000, China

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Henan Tumor Hospital

    Zhengzhou, Henan, 450003, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Nanjing Drug Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730013, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650106, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.