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)

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa pegol (N8-GP)	N8-GP will be injected into a vein (intravenous injections) every 4 days in at least 28 weeks

Timeline

• Start date: 2021-09-27
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2021-10-18
• Last updated: 2026-01-06
• Results posted: 2024-01-18

Locations

11 sites across 1 country: China

Regulatory

• FDA-regulated drug study