Hemophilia A study: GS1191-0445 injection
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 IV infusion (through 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
- The study aims to see if the single dose is safe and works to produce factor VIII, a protein that helps blood clot, in people with hemophilia A.
- Who it's for
- Chinese individuals who have hemophilia A.
- What's involved
- Participants receive one intravenous infusion of the gene‑therapy drug and then have regular clinic visits for blood tests and other safety checks.
- Time commitment
- One infusion followed by scheduled follow‑up visits over several months to monitor safety and effectiveness.
- 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
- 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.
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
- Active systemic immune disease.
The study team makes the final eligibility decision.
Where it is enrolling
- Jinan, Shandong, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Jinan, Shandong, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.