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

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

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 Overview

• Status: Completed
• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Intervention / Treatment: Drug: turoctocog alfa

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population are haemophilia A patients who based on the indication will benefit from treatment with turoctocog alfa. No limitation has been set to the severity of haemophilia A, gender, age, previously treated and untreated patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
turoctocog alfa; Patients with haemophilia A	Drug: turoctocog alfa; Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse reactions	Count and % of events	3-36 months after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): June 16, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
• Other Study ID Numbers: NN7008-4253; U1111-1171-9845 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No