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

NCT03179748 — Completed, 10 participants, Novo Nordisk A/S

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

Registry	NCT03179748
Status	Completed
Study type	Observational
Enrollment	10 (Actual)
Sponsor	Novo Nordisk A/S (Industry)
Conditions	Congenital Bleeding Disorder, Haemophilia A
Interventions	turoctocog alfa (Drug)
Dates	start 2018-06-20, primary completion 2021-06-16, completion 2021-06-16, first posted 2017-06-07, last updated 2021-11-15
Locations	1 site in Mexico

-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

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+Arms and interventions

Arm	Type	Interventions	Description
turoctocog alfa		Drug: turoctocog alfa	Patients with haemophilia A

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

+Outcome measures

Primary outcomes

Frequency of adverse reactions [3-36 months after enrollment]: Count and % of events

Secondary outcomes

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
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
Number of bleeding episodes [3-36 months after enrollment]: Count of episodes

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Novo Nordisk Investigational Site	Monterrey, Nuevo León	Mexico