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

Congenital Bleeding Disorder Clinical Trial

Official title:

A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207218
• Other study ID #: NN7008-4105
• Secondary ID: U1111-1144-8212
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

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

External Links

•   Clinical Trials at Novo Nordisk