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OpenTrials
Completed

NCT Number: NCT03179748

Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Male and female patients with haemophilia A
  • Age range is 0 years and above
  • The decision to initiate treatment with commercially available turoctocog alfa 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

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Known or suspected allergy to turoctocog alfa or related products
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Treatment and study plan

turoctocog alfa

Drug

Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician

Primary outcomes

  1. Frequency of adverse reactions

    Time frame: 3-36 months after enrollment

    Count and % of events

Secondary outcomes

  1. Frequency of adverse events

    Time frame: 3-36 months after enrollment

    Count and % of events

  2. Efficacy in treatment of bleeds

    Time frame: 3-36 months after enrollment

    Rated: Excellent, Good, Moderate or none

  3. Consumption of turoctocog alfa for prophylaxis

    Time frame: 3-36 months after enrollment

    Measured in IU/kg/dose

  4. Consumption of turoctocog alfa for treatment of bleeds

    Time frame: 3-36 months after enrollment

    Measured in IU/kg/bleeding episode

  5. Consumption of turoctocog alfa for surgery and post-surgical period

    Time frame: 3-36 months after enrollment

    Measured in IU/kg

  6. Number of patients with confirmed inhibitors

    Time frame: 3-36 months after enrollment

    Count of presence of inhibitors

  7. Number of patients with allergic/hypersensitivity reactions to turoctocog alfa

    Time frame: 3-36 months after enrollment

    Count of episodes

  8. Number of bleeding episodes

    Time frame: 3-36 months after enrollment

    Count of episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2017
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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