A Study Following Males With Haemophilia A on Prophylaxis With Esperoct® (pathfinder9)

December 22, 2023 updated by: Novo Nordisk A/S

A Multinational, Prospective, Open Labelled, Non-controlled, Non-interventional Post-authorisation Study of Turoctocog Alfa Pegol (N8-GP) During Long-term Routine Prophylaxis and Treatment of Bleeding Episodes in Patients With Haemophilia A

This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

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

  • Austria
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1527
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • Novo Nordisk Investigational Site
      • Hradec Kralove, Czechia, 500 05
        • Novo Nordisk Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novo Nordisk Investigational Site
      • Tartu, Estonia, 50406
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Bonn, Germany, 53127
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1134
        • Novo Nordisk Investigational Site
  • Italy
      • Parma, Italy, 43126
        • Novo Nordisk Investigational Site
      • Torino, Italy, 10126
        • Novo Nordisk Investigational Site
      • Vicenza, Italy, 36100
        • Novo Nordisk Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Novo Nordisk Investigational Site
      • Panevezys, Lithuania, LT-35144
        • Novo Nordisk Investigational Site
      • Vilnius, Lithuania, LT-08661
        • Novo Nordisk Investigational Site
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Novo Nordisk Investigational Site
      • Porto, Portugal, 4200-319
        • Novo Nordisk Investigational Site
  • Slovakia
      • Kosice, Slovakia, 04001
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Novo Nordisk Investigational Site
  • Spain
      • Málaga, Spain, 29009
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8032
        • 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

No

Sampling Method

Probability Sample

Study Population

Patients with haemophilia A

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.
  • Male patients of all ages, according to local label, are allowed in this study
  • Diagnosis of severe or moderate Haemophilia A

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Known or suspected hypersensitivity to N8-GP or related products
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation
  • Clinical suspicion or presence of FVIII inhibitors at time of inclusion

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
N8-GP
Patients with haemophilia A
Drug: Turoctocog alfa pegol (N8-GP)
Patients will be treated with commercially available N8-GP for prophylaxis and treatment of bleeding episodes according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available N8-GP 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 Events (AEs) reported during the study period
Time Frame: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years
Count of events
From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Serious Adverse Events (SAEs) reported during the study period
Time Frame: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years
Count of events
From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years

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 Transparency (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)

October 23, 2020

Primary Completion (Estimated)

June 3, 2027

Study Completion (Estimated)

June 3, 2027

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7088-4029
  • EUPAS36536 (Registry Identifier: EU PAS Register)
  • U1111-1235-6007 (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.

Clinical Trials on Haemophilia A

Clinical Trials on Turoctocog alfa pegol (N8-GP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe