Plain-English translation of NCT02234310 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Hemophilia research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial tested (recombinant coagulation factor IX Fc fusion protein), a new injectable medication designed to help the blood clot in people with severe hemophilia B who had never received treatment before. The study examined whether the medication was safe and how well it prevented and treated bleeding episodes. Participants received regular injections of the medication, with doses adjusted based on their individual needs and how their body responded.
Hemophilia B is a bleeding disorder where the body doesn't make enough of a natural clotting protein, putting patients at serious risk of dangerous bleeds. This trial was designed to see if this new, longer-acting medication could effectively prevent bleeding and reduce the burden of frequent treatment in newly diagnosed patients.
Participants received weekly injections of the medication by IV (intravenous) infusion. The study continued until participants had received at least 50 doses of the medication (spread over several months) or until they withdrew from the study. During this time, doctors monitored participants for safety, measured how well the medication prevented bleeding, and adjusted doses as needed based on how well the medication worked and the participant's bleeding patterns.
AI-generated summary from trial data · Oct 12, 2026 · Not medical advice
United States