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NCT03179748 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03179748
Other study ID # NN7008-4253
Secondary ID U1111-1171-9845
Status Completed
Phase
First received
Last updated
Start date June 20, 2018
Est. completion date June 16, 2021

Study information
Verified date November 2021
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 16, 2021
Est. primary completion date June 16, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Mexico Novo Nordisk Investigational Site Monterrey Nuevo León

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of adverse reactions Count and % of events 3-36 months after enrollment
Secondary Frequency of adverse events Count and % of events 3-36 months after enrollment
Secondary Efficacy in treatment of bleeds Rated: Excellent, Good, Moderate or none 3-36 months after enrollment
Secondary Consumption of turoctocog alfa for prophylaxis Measured in IU/kg/dose 3-36 months after enrollment
Secondary Consumption of turoctocog alfa for treatment of bleeds Measured in IU/kg/bleeding episode 3-36 months after enrollment
Secondary Consumption of turoctocog alfa for surgery and post-surgical period Measured in IU/kg 3-36 months after enrollment
Secondary Number of patients with confirmed inhibitors Count of presence of inhibitors 3-36 months after enrollment
Secondary Number of patients with allergic/hypersensitivity reactions to turoctocog alfa Count of episodes 3-36 months after enrollment
Secondary Number of bleeding episodes Count of episodes 3-36 months after enrollment
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