To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan

NCT ID: NCT02207218

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-04

Study Completion Date

2020-11-10

Brief Summary

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This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.

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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NovoEight®

turoctocog alfa

Intervention Type DRUG

No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.

Interventions

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turoctocog alfa

No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed 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 the diagnosis of haemophilia A
* Age range is 0 year and above
* A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician

Exclusion Criteria

* Known or suspected allergy to study product(s) or related products
* Previous participation in this study. Participation is defined as informed consent obtained
* 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

Principal Investigators

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Global Clinical Registry GCR, 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Suginami-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1144-8212

Identifier Type: OTHER

Identifier Source: secondary_id

NN7008-4105

Identifier Type: -

Identifier Source: org_study_id