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

NCT ID: NCT03179748

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-20

Study Completion Date

2021-06-16

Brief Summary

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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

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Conditions

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Congenital Bleeding Disorder Haemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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turoctocog alfa

Patients with haemophilia A

turoctocog alfa

Intervention Type DRUG

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

Interventions

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turoctocog alfa

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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U1111-1171-9845

Identifier Type: OTHER

Identifier Source: secondary_id

NN7008-4253

Identifier Type: -

Identifier Source: org_study_id