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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02207218
Collaborator
(none)
40
Enrollment
2
Locations
75.2
Actual Duration (Months)
20
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: turoctocog alfa

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Aug 4, 2014
Actual Primary Completion Date :
Nov 10, 2020
Actual Study Completion Date :
Nov 10, 2020

Arms and Interventions

Arm Intervention/Treatment
NovoEight®

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.

Outcome Measures

Primary Outcome Measures

  1. Frequency of Adverse Events (AEs) [Week 0- 104]

Secondary Outcome Measures

  1. Frequency of Adverse Reactions (ARs) [Week 0- 104]

  2. Frequency of Serious Adverse Events (SAEs) [Week 0- 104]

  3. Frequency of Serious Adverse Reactions (SARs) [Week 0- 104]

  4. 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]

  5. 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]

  6. Annualised bleeding rate for patients using NovoEight® for preventive regimen [Week 0- 104]

  7. Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient) [Week 0- 104]

  8. Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode) [Week 0- 104]

  9. Consumption of NovoEight® per month (IU/kg BW/month) for prevention [Week 0- 104]

  10. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Suginami-ku, Tokyo Japan 1670035
2 Novo Nordisk Investigational Site Tokyo Japan 167-0035

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry GCR, 1452, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02207218
Other Study ID Numbers:
  • NN7008-4105
  • U1111-1144-8212
First Posted:
Aug 4, 2014
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:
Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders

Study Results

No Results Posted as of Nov 15, 2021