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
• 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
• 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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

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