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

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: NCT04334057
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2020
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Haemophilia A Drug: Turoctocog alfa pegol

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Haemophilia A patients in routine clinical practice in Japan
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.
  • 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.

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): NCT04334057


Locations
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Japan
Novo Nordisk Investigational Site
Gifu, Japan, 501-1194
Novo Nordisk Investigational Site
Iruma-gun, Saitama, Japan, 350 0495
Novo Nordisk Investigational Site
Kanagawa, Japan, 216-8511
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, 113-8603
Novo Nordisk Investigational Site
Tokyo, Japan, 167-0035
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04334057    
Other Study ID Numbers: NN7088-4484
U1111-1216-4626 ( Other Identifier: World Health Organization (WHO) )
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: November 30, 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