- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334057
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
November 27, 2023 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
15
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
-
-
-
Fukuoka, Japan, 830-0011
- Novo Nordisk Investigational Site
-
Gifu, Japan, 501-1194
- Novo Nordisk Investigational Site
-
Iruma-gun, Saitama, Japan, 350 0495
- Novo Nordisk Investigational Site
-
Kamigyo-ku, Kyoto, Japan, 602-8566
- Novo Nordisk Investigational Site
-
Kanagawa, Japan, 216-8511
- Novo Nordisk Investigational Site
-
Nara, Japan, 634-8522
- 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, 167-0035
- Novo Nordisk Investigational Site
-
Tokyo, Japan, 160-0023
- Novo Nordisk Investigational Site
-
Tokyo, Japan, 113-8603
- Novo Nordisk Investigational Site
-
Yamagata, Japan, 998-8501
- Novo Nordisk Investigational Site
-
Yokohama-shi, Kanagawa, Japan, 241-0811
- 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
N/A
Sampling Method
Non-Probability Sample
Study Population
Haemophilia A patients in routine clinical practice in Japan
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.
- 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.
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 |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adverse reactions (ARs) reported during the observation period
Time Frame: From baseline (week 0) to end of study (week 104)
|
Count
|
From baseline (week 0) to end of study (week 104)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of serious adverse events (SAEs) reported during the observation period
Time Frame: From baseline (week 0) to end of study (week 104)
|
Count
|
From baseline (week 0) to end of study (week 104)
|
Number of serious adverse reactions (SARs) reported during the observation period
Time Frame: From baseline (week 0) to end of study (week 104)
|
Count
|
From baseline (week 0) to end of study (week 104)
|
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
|
From baseline (week 0) to end of study (week 104)
|
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
|
From baseline (week 0) to end of study (week 104)
|
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
|
From baseline (week 0) to end of study (week 104)
|
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
|
From baseline (week 0) to end of study (week 104)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Reporting Anchor & Disclosure (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)
March 31, 2021
Primary Completion (Estimated)
February 28, 2025
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
April 2, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN7088-4484
- U1111-1216-4626 (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
-
Novo Nordisk A/SCompletedHaemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BFrance, United States, India, Mexico, United Kingdom, Netherlands, Sweden, Korea, Republic of, Spain, Switzerland, Serbia, Turkey, Bulgaria, Italy, Japan, Poland, South Africa, Croatia, Algeria, Australia, Bosnia and Herzegovina, ... and more
-
Novo Nordisk A/SCompletedEpidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries (HAEMOcare)Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BIndia, Morocco, South Africa, Oman
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BSpain
-
Novo Nordisk A/SRecruitingHaemophilia A With Inhibitors | Haemophilia AUnited States, Korea, Republic of, France, Spain, Romania, Canada, Taiwan, China, Lithuania, Netherlands, India, South Africa, Russian Federation, Austria, Belgium, Czechia, Denmark, Germany, Ireland, Italy, Japan, Latvia, Malaysia, M... and more
-
American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
-
Novo Nordisk A/SWithdrawnHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia B
-
Novo Nordisk A/SRecruitingHaemophilia A With Inhibitors | Haemophilia ATaiwan, Canada, Spain, Netherlands, Korea, Republic of, India, United States, United Kingdom, Portugal, Lithuania, Turkey, China, South Africa, Ireland, Italy, France, Japan, Poland, Belgium, Germany, Malaysia, Austria, Bulgaria, Denmark and more
-
Novo Nordisk A/SActive, not recruitingHaemophilia A With Inhibitors | Haemophilia ASpain, Korea, Republic of, Canada, United Kingdom, United States, Germany, South Africa, Italy, Austria, Belgium, France, Japan
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia B | Relatives to/Carers of PatientsSpain, Canada, United Kingdom
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BUnited States
Clinical Trials on Turoctocog alfa pegol
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AUnited States, Netherlands, Spain, Germany, France, Denmark
-
Novo Nordisk A/SEnrolling by invitationHaemophilia ADenmark
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AUnited States, Austria, Serbia, Germany, Japan, France
-
Novo Nordisk A/SRecruiting
-
Novo Nordisk A/SEnrolling by invitationHaemophilia AAustria, Spain, Bulgaria, Croatia, Estonia, Hungary, Italy, Lithuania, Portugal, Greece, Germany, Czechia, Slovenia, Switzerland, Slovakia
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AUnited States, Netherlands, Spain, Switzerland, Taiwan, Turkey, United Kingdom, Croatia, Germany, Brazil, France, Japan, Australia, Hungary, Israel, Korea, Republic of, Lithuania, Portugal, Ukraine, Greece, Italy, Denmark, Norway, Canada and more
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AFrance, United States, Denmark, Netherlands, Sweden, Spain, Germany, Switzerland, Taiwan, Japan, United Kingdom, Croatia, Italy, Malaysia, Brazil, Australia, Hungary, Israel, Turkey, Puerto Rico, Norway, Korea, Republic of, Bulgaria, Russian...
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AFrance, United States, Denmark, Netherlands, Sweden, Spain, Germany, Switzerland, Taiwan, United Kingdom, Croatia, Malaysia, Brazil, Australia, Hungary, Israel, Turkey, Italy, Japan, Norway, Bulgaria
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AFrance, United States, Austria, Spain, Taiwan, Japan, Italy, Bulgaria, Malaysia, Algeria, Australia, Canada, Israel, Thailand, Argentina, Greece, Romania, Germany