Plain-English translation of NCT05630651 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Hemophilia B research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is testing a new gene therapy called ZS801 for people with hemophilia B—a bleeding disorder where the body doesn't make enough of a clotting protein called factor IX. Researchers want to see if a single infusion of this medication can safely boost your body's ability to make this clotting factor and reduce bleeding episodes. You would be monitored closely for 52 weeks after receiving the treatment.
Hemophilia B patients with very low factor IX levels currently need regular infusions of clotting factor to prevent life-threatening bleeding. This medication uses gene therapy technology to help the body produce its own clotting factor, potentially offering a longer-lasting solution than current treatments.
You likely qualify if…
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You would attend screening visits over 6 weeks before receiving a single intravenous infusion of the medication in a hospital or clinic setting. After that, you would return for safety and effectiveness check-ups over 52 weeks, which may include blood tests, physical exams, and assessments of your bleeding episodes and joint health. The study team will monitor how well your body responds to the treatment and watch for any side effects.
AI-generated summary from trial data · Jun 6, 2026 · Not medical advice
China
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Enrollment target
~6 participants
Started
April 2023
Primary completion
December 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years – 65 Years
Sex
Male only
Last updated on clinicaltrials.gov in February 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Lei Zhang, MD
Institute of Hematology & Blood Diseases Hospital, China
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.