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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 23, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date April 2, 2020
First Posted Date April 3, 2020
Last Update Posted Date November 23, 2021
Actual Study Start Date March 31, 2021
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2020)
Number of adverse reactions (ARs) reported during the observation period [ Time Frame: From baseline (week 0) to end of study (week 104) ]
Count
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 2, 2020)
  • Number of serious adverse events (SAEs) reported during the observation period [ Time Frame: From baseline (week 0) to end of study (week 104) ]
    Count
  • Number of serious adverse reactions (SARs) reported during the observation period [ Time Frame: From baseline (week 0) to end of study (week 104) ]
    Count
  • 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
  • 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
  • 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
  • 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
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 Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
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
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.
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 Non-Probability Sample
Study Population Haemophilia A patients in routine clinical practice in Japan
Condition Haemophilia A
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Drug: Turoctocog alfa pegol
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: April 2, 2020)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2025
Estimated Primary Completion Date February 28, 2025   (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.
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04334057
Other Study ID Numbers NN7088-4484
U1111-1216-4626 ( 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 Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2021