BridgeMD
New treatment option for Hemophilia A
Official title To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
ClinicalTrials.gov ID: NCT06833983
What this study is testing
What is GS1191-0445 injection?
GS1191-0445 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemophilia a.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-arm, open-label, multicenter study evaluating the efficacy and safety of GS1191-0445 injection as a single dose in Chinese subjects with hemophilia A. GS1191-0445 is an AAV8-based gene therapy vector designed to express B-domain deleted human factor VIII (FVIII) under the regulation of a human liver-specific promoter.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, men only
You may be able to join if
- Understand the purpose and risks of the study and provide informed consent in accordance with national and local privacy laws:
- Subject must be male, aged \>18 years old at the time of signing informed consent, and ≤65 years old:
- Participants with confirmed hemophilia A in their pre-admission history and based on clinical laboratory examination ;
- people had used FVIII products for at least 150 exposure days (ED) before enrollment;
- Subject has no prior history of FVIII inhibitors;
You likely can't join if
- The subject has any hemorrhagic disorder not related to hemophilia A,
- Abnormal liver function test results of people during screening.
- Abnormal laboratory examination of people during screening
- The subject has acute or chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; Or are receiving antiviral treatment...
- Active systemic immune disease.
See the full eligibility criteria
- Understand the purpose and risks of the study and provide informed consent in accordance with national and local privacy laws:
- Subject must be male, aged \>18 years old at the time of signing informed consent, and ≤65 years old:
- Participants with confirmed hemophilia A in their pre-admission history and based on clinical laboratory examination ;
- people had used FVIII products for at least 150 exposure days (ED) before enrollment;
- Subject has no prior history of FVIII inhibitors;
- people agree to use a reliable barrier contraceptive method from the date of signing the informed consent
- Subject is willing and able to follow planned visits, treatment plans, and other study procedures.
- The subject has any hemorrhagic disorder not related to hemophilia A,
- Abnormal liver function test results of people during screening.
- Abnormal laboratory examination of people during screening
- 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;
- Active systemic immune disease.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Tangshan, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Tangshan, Hebei, China; Zhengzhou, Henan, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.