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

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Interventions: Drug: turoctocog alfa

• Registration Number: NCT03179748
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Study Start: 2018-06-20
• Primary Completion: 2021-06-16
• Study Completion: 2021-06-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
turoctocog alfa	turoctocog alfa	Patients with haemophilia A

Primary Outcome Measures

Name	Time	Method
Frequency of adverse reactions	3-36 months after enrollment	Count and % of events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇲🇽 Monterrey, Nuevo León, Mexico