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One-Time gene shot aims to stop bleeding in hemophilia a

NCT ID NCT06833983

Disease control Sponsor: Gritgen Therapeutics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single-dose gene therapy called GS1191-0445 in 50 Chinese men with hemophilia A. The treatment uses a harmless virus to deliver a working gene to the liver, helping the body produce its own clotting factor. The goal is to reduce bleeding episodes and the need for regular factor infusions. Participants will be monitored for safety and effectiveness over one year.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2030

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

18 to 65 years

Sex

Male participants only

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: 1. Understand the purpose and risks of the study and provide informed consent in accordance with national and local privacy laws: 2. Subject must be male, aged \>18 years old at the time of signing informed consent, and ≤65 years old: 3. Participants with confirmed hemophilia A in their pre-admission history and based on clinical laboratory examination ; 4. Subjects had used FVIII products for at least 150 exposure days (ED) before enrollment; 5. Subject has no prior history of FVIII inhibitors; 6. Subjects agree to use a reliable barrier contraceptive method from the date of signing the informed consent 7. Subject is willing and able to follow planned visits, treatment plans, and other study procedures. Exclusion Criteria: 1. The subject has any hemorrhagic disorder not related to hemophilia A, 2. Abnormal liver function test results of subjects during screening. 3. Abnormal laboratory examination of subjects during screening 4. The subject has acute or chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; Or are receiving antiviral treatment for hepatitis B and C; 5. Active systemic immune disease.

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Provincial Hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, 230001, China

  • Central Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250013, China

  • First Hospital of Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730099, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450003, China

  • Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Jiangxi Provincial People's Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 344001, China

  • Nanfang Hospital Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210000, China

  • North China University of Science and Technology Affiliated Hospital

    NOT_YET_RECRUITING

    Tangshan, Hebei, 063000, China

  • Peking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • The second Affiliated Hospital of Kunming Medical University

    NOT_YET_RECRUITING

    Kunming, Yunnan, 650101, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 410028, China

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