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

November 27, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 830-0011
        • Novo Nordisk Investigational Site
      • Gifu, Japan, 501-1194
        • Novo Nordisk Investigational Site
      • Iruma-gun, Saitama, Japan, 350 0495
        • Novo Nordisk Investigational Site
      • Kamigyo-ku, Kyoto, Japan, 602-8566
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 216-8511
        • Novo Nordisk Investigational Site
      • Nara, Japan, 634-8522
        • Novo Nordisk Investigational Site
      • Okinawa, Japan, 901-1193
        • Novo Nordisk Investigational Site
      • Saitama, Japan, 350-0225
        • Novo Nordisk Investigational Site
      • Shiga, Japan, 520-2145
        • Novo Nordisk Investigational Site
      • Shizuoka, Japan, 420-8660
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 167-0035
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 160-0023
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 113-8603
        • Novo Nordisk Investigational Site
      • Yamagata, Japan, 998-8501
        • Novo Nordisk Investigational Site
      • Yokohama-shi, Kanagawa, Japan, 241-0811
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Haemophilia A patients in routine clinical practice in Japan

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with haemophilia A
New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse reactions (ARs) reported during the observation period
Time Frame: From baseline (week 0) to end of study (week 104)
Count
From baseline (week 0) to end of study (week 104)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of serious adverse events (SAEs) reported during the observation period
Time Frame: From baseline (week 0) to end of study (week 104)
Count
From baseline (week 0) to end of study (week 104)
Number of serious adverse reactions (SARs) reported during the observation period
Time Frame: From baseline (week 0) to end of study (week 104)
Count
From baseline (week 0) to end of study (week 104)
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
From baseline (week 0) to end of study (week 104)
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
From baseline (week 0) to end of study (week 104)
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
From baseline (week 0) to end of study (week 104)
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
From baseline (week 0) to end of study (week 104)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor & Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7088-4484
  • U1111-1216-4626 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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