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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574076
Recruitment Status : Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Haemophilia A Drug: Turoctocog alfa pegol (N8-GP)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : June 3, 2027
Estimated Study Completion Date : June 3, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with haemophilia A
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574076


Locations
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Austria
Novo Nordisk Investigational Site
Wien, Austria, 1090
Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1527
Croatia
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Germany
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Italy
Novo Nordisk Investigational Site
Torino, Italy, 10126
Novo Nordisk Investigational Site
Vicenza, Italy, 36100
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1000
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04574076    
Other Study ID Numbers: NN7088-4029
EUPAS36536 ( Registry Identifier: EU PAS Register )
U1111-1235-6007 ( Other Identifier: World Health Organization (WHO) )
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn