Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 30, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date September 21, 2020
First Posted Date October 5, 2020
Last Update Posted Date November 30, 2021
Actual Study Start Date October 23, 2020
Estimated Primary Completion Date June 3, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 28, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with haemophilia A
Condition Haemophilia A
Intervention 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.
Study Groups/Cohorts N8-GP
Patients with haemophilia A
Intervention: Drug: Turoctocog alfa pegol (N8-GP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: September 28, 2020)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 3, 2027
Estimated Primary Completion Date June 3, 2027   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Bulgaria,   Croatia,   Germany,   Greece,   Hungary,   Italy,   Portugal,   Slovenia,   Switzerland
Removed Location Countries Denmark
 
Administrative Information
NCT Number NCT04574076
Other Study ID Numbers NN7088-4029
EUPAS36536 ( Registry Identifier: EU PAS Register )
U1111-1235-6007 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Clinical Transparency (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2021