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

November 12, 2021 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Suginami-ku, Tokyo, Japan, 1670035
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 167-0035
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in routine clinical setting in Japan.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events (AEs)
Time Frame: Week 0- 104
Week 0- 104

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2014

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

November 10, 2020

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7008-4105
  • U1111-1144-8212 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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