NCT04334057

Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®

Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®. A Multi-centre, Prospective, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Esperoct® in Haemophilia A Patients Under Routine Clinical Practice Conditions in Japan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.

Conditions

• Haemophilia A

Interventions

Type	Name	Description
DRUG	Turoctocog alfa pegol	Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-11-30
• Completion: 2024-01-10
• First posted: 2020-04-03
• Last updated: 2025-08-29

Locations

19 sites across 1 country: Japan