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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02207218
Other study ID # NN7008-4105
Secondary ID U1111-1144-8212
Status Completed
Phase
First received
Last updated
Start date August 4, 2014
Est. completion date November 10, 2020

Study information

Verified date November 2021
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 10, 2020
Est. primary completion date November 10, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
Japan Novo Nordisk Investigational Site Suginami-ku, Tokyo
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events (AEs) Week 0- 104
Secondary Frequency of Adverse Reactions (ARs) Week 0- 104
Secondary Frequency of Serious Adverse Events (SAEs) Week 0- 104
Secondary Frequency of Serious Adverse Reactions (SARs) Week 0- 104
Secondary Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively Week 0- 104
Secondary Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None Week 0- 104
Secondary Annualised bleeding rate for patients using NovoEight® for preventive regimen Week 0- 104
Secondary Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient) Week 0- 104
Secondary Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode) Week 0- 104
Secondary Consumption of NovoEight® per month (IU/kg BW/month) for prevention Week 0- 104
Secondary Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen Week 0- 104
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