drugset / Trial / NCT05082116

Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)

NCT05082116 ↗

Phase 3 Completed 36 enrolled Novo Nordisk A/S
NaSingle-groupOpen-labelTreatment

Summary

The study investigates how well the medicine called turoctocog alfa pegol (N8-GP) works in previously treated Chinese patients with severe haemophilia A. Participants will be treated with N8-GP. This is a medicine that doctors can already prescribe in other countries. The medicine will be injected into a vein (intravenous injections) and blood samples will be collected. The study will last for about 7-8 months. Participants will have between 8 and 15 visits to the clinic and possibly a number of phone calls with the study doctor.

Timeline

Start
2021-09-27
Primary completion
2022-12-28
Completion
2022-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject turoctocog alfa pegol Protein / enzyme biologic 50 iu/kg Intravenous

Indications