Plain-English translation of NCT05641610 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Hemophilia B research guide →Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing ZS801, a gene therapy designed to help your body produce its own blood-clotting protein (factor IX). Hemophilia B is a genetic bleeding disorder where your body cannot make enough of this protein, leading to frequent and sometimes dangerous bleeding. This treatment works by delivering instructions to your cells so they can start making the clotting protein you need.
Current hemophilia B treatment requires frequent intravenous infusions of clotting protein, which can lead to joint damage and other complications over time. This medication offers a potential new approach: a single infusion that could help your body produce its own clotting protein long-term, reducing the need for ongoing treatments.
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You will first go through screening visits over 6 to 8 weeks to make sure the treatment is safe for you. Then you will receive a single intravenous infusion of the medication at the hospital. After that, you will be monitored for safety and effectiveness for 52 weeks (one year) through regular follow-up visits and blood tests. The trial will track whether the medication helps your body produce more clotting protein and reduces your bleeding events.
AI-generated summary from trial data · Jun 6, 2026 · Not medical advice
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