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

NCT03179748 | Completed

• 2 other identifiers: NN7008-4253U1111-1171-9845
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Congenital Bleeding Disorder; Haemophilia A

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse reactions

  Count and % of events

  3-36 months after enrollment

Secondary Outcomes (8)

• Frequency of adverse events

  3-36 months after enrollment

• Efficacy in treatment of bleeds

  3-36 months after enrollment

• Consumption of turoctocog alfa for prophylaxis

  3-36 months after enrollment

• Consumption of turoctocog alfa for treatment of bleeds

  3-36 months after enrollment

• Consumption of turoctocog alfa for surgery and post-surgical period

  3-36 months after enrollment

Study Arms (1)

turoctocog alfa

Patients with haemophilia A

Drug: turoctocog alfa

Interventions

turoctocog alfa DRUG

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

turoctocog alfa

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII N8

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 7, 2017
• Study Start: June 20, 2018
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)