Skip to main content
OpenTrials
Completed

NCT Number: NCT04334057

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Kurume University Hospital, Pediatrics, Fukuoka, Japan

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • 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.
  • Diagnosis of haemophilia A in males or females, no age limitation.
  • New patients who have not previously been exposed to Esperoct®.

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Known or suspected hypersensitivity to study product or related products.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Treatment and study plan

Turoctocog alfa pegol

Drug

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.

Primary outcomes

  1. Number of adverse reactions (ARs) reported during the observation period

    Time frame: From baseline (week 0) to end of study (week 104)

    Count

Secondary outcomes

  1. Number of serious adverse events (SAEs) reported during the observation period

    Time frame: From baseline (week 0) to end of study (week 104)

    Count

  2. Number of serious adverse reactions (SARs) reported during the observation period

    Time frame: From baseline (week 0) to end of study (week 104)

    Count

  3. Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period

    Time frame: From baseline (week 0) to end of study (week 104)

    Count

  4. Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR)

    Time frame: From baseline (week 0) to end of study (week 104)

    Count

  5. Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds

    Time frame: From baseline (week 0) to end of study (week 104)

    Count, assessed based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure

  6. Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures

    Time frame: From baseline (week 0) to end of study (week 104)

    Count, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 3, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.