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COMPLETED
NCT04334057

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

23

Start Date

2021-03-31

Completion Date

2024-01-10

Last Updated

2026-06-15

Healthy Volunteers

Not specified

Conditions

Interventions

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.

Locations (20)

Kurume University Hospital, Pediatrics

Fukuoka, Japan

Gifu University Hospital_The Third Dept. of Internal Medicine

Gifu, Japan

Gifu University Hospital

Gifu, Japan

Saitama Medical University Hospital, Pediatrics

Iruma-gun, Saitama, Japan

University Hospital Kyoto Prefectual University of Medicine

Kamigyo-ku, Kyoto, Japan

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, Japan

St. Marianna University School of Medicine Hospital

Kanagawa, Japan

Nara Medical University Hospital_Pediatrics

Nara, Japan

Nanbu Medical Center & Children's Medical Center_Pediatric Hematology

Okinawa, Japan

Shibuya Children's Clinic, Department of Pediatric

Saitama, Japan

Lake Children Clinic

Shiga, Japan

Shizuoka Children's Hospital, Hematology-Oncology

Shizuoka, Japan

Shizuoka Children's Hospital

Shizuoka, Japan

Nippon Medical School Hospital_Haematology

Tokyo, Japan

Tokyo Medical Univ. Hospital_Laboratory Medicine

Tokyo, Japan

Tokyo Medical Univ. Hospital

Tokyo, Japan

Ogikubo Hospital_Blood Coagulation

Tokyo, Japan

Nihonkai Sogo Hospital_Internal Medicine

Yamagata, Japan

Nihonkai Sogo Hospital

Yamagata, Japan

St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,

Yokohama-shi, Kanagawa, Japan