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NCT04334057Completed

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

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

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
23 (actual)
First submitted
2 Apr 2020
Start date
31 Mar 2021
Primary completion date
30 Nov 2023
Lead sponsor
Novo Nordisk A/S
Diseases
Haemophilia
NCT number
NCT04334057

What you commit to

  • Study type: Observational
  • Participants enrolled: 23
  • From 31 Mar 2021 to the primary completion date, 30 Nov 2023
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in this study. Participation is defined as having given informed consent in this study.

Other illness

  • Known or suspected hypersensitivity to study product or related products.

Other

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Who the study is looking for

  • 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®.

Sex: All

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kurume University Hospital, Pediatrics
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Gifu University Hospital_The Third Dept. of Internal Medicine
Coordinator of this site? Confirm its status
GifuJapanUnknown status
Gifu University Hospital
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GifuJapanUnknown status
Saitama Medical University Hospital, Pediatrics
Coordinator of this site? Confirm its status
Iruma-gun, SaitamaJapanUnknown status
University Hospital Kyoto Prefectual University of Medicine
Coordinator of this site? Confirm its status
Kamigyo-ku, KyotoJapanUnknown status
St. Marianna University School of Medicine Hospital_Pediatrics
Coordinator of this site? Confirm its status
KanagawaJapanUnknown status
St. Marianna University School of Medicine Hospital
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KanagawaJapanUnknown status
Nara Medical University Hospital_Pediatrics
Coordinator of this site? Confirm its status
NaraJapanUnknown status
Nanbu Medical Center & Children's Medical Center_Pediatric Hematology
Coordinator of this site? Confirm its status
OkinawaJapanUnknown status
Shibuya Children's Clinic, Department of Pediatric
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SaitamaJapanUnknown status
Lake Children Clinic
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ShigaJapanUnknown status
Shizuoka Children's Hospital, Hematology-Oncology
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ShizuokaJapanUnknown status
Shizuoka Children's Hospital
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ShizuokaJapanUnknown status
Ogikubo Hospital_Blood Coagulation
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TokyoJapanUnknown status
Nippon Medical School Hospital_Haematology
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TokyoJapanUnknown status
Tokyo Medical Univ. Hospital
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TokyoJapanUnknown status
Tokyo Medical Univ. Hospital_Laboratory Medicine
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TokyoJapanUnknown status
Nihonkai Sogo Hospital_Internal Medicine
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YamagataJapanUnknown status
Nihonkai Sogo Hospital
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YamagataJapanUnknown status
St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,
Coordinator of this site? Confirm its status
Yokohama-shi, KanagawaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.