drugset / Trial / NCT05365217

A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B

NCT05365217

Phase 3 Completed 30 enrolled Novo Nordisk A/S
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B. Participants will be treated with N9-GP. This is a medicine that doctors can already prescribe in other countries. The medicine will be injected into a vein (intravenous injection). At the visits to the clinic, the medicine will be injected by the study doctor. When treating themselves at home, participants inject the medicine using a needle and vial set. The study will last for about 12-16 months. The participants will have between 9 and 19 visits to the clinic and possibly also some phone calls with the study doctor. At all visits to the clinic, the participants will have blood samples taken.

Timeline

Start
2022-05-18
Primary completion
2024-04-11
Completion
2024-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject nonacog beta pegol Protein / enzyme biologic Intravenous

Indications