Brief Title
Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients
Official Title
Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients
Brief Summary
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
Study Type
Observational
Primary Outcome
Frequency of adverse reactions
Secondary Outcome
Frequency of adverse events
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
turoctocog alfa
Description: Patients with haemophilia A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
June 20, 2018
Completion Date
June 16, 2021
Primary Completion Date
June 16, 2021
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) - 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT03179748
Organization ID
NN7008-4253
Secondary IDs
U1111-1171-9845
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
, ,
Verification Date
November 2021