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

Last updated: November 27, 2023
Sponsor: Novo Nordisk A/S
Overall Status: Active - Enrolling

Phase

N/A

Condition

Hemophilia

Treatment

Turoctocog alfa pegol

Clinical Study ID

NCT04334057
NN7088-4484
U1111-1216-4626
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activitiesare any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available Esperoct® has been madeby the patient/Legally Acceptable Representative (LAR) and the treating physicianbefore 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

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having giveninformed consent in this study.
  • Known or suspected hypersensitivity to study product or related products.
  • Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Turoctocog alfa pegol
Phase:
Study Start date:
March 31, 2021
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Novo Nordisk Investigational Site

    Fukuoka, 830-0011
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Gifu, 501-1194
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Iruma-gun, Saitama, 350 0495
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kamigyo-ku, Kyoto, 602-8566
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Nara, 634-8522
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Okinawa, 901-1193
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Saitama, 350-0225
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shiga, 520-2145
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shizuoka, 420-8660
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 113-8603
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yamagata, 998-8501
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokohama-shi, Kanagawa, 241-0811
    Japan

    Site Not Available

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