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NCT Number: NCT02207218

To Investigate 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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Suginami-ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

turoctocog alfa

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.

Primary outcomes

  1. Frequency of Adverse Events (AEs)

    Time frame: Week 0- 104

Secondary outcomes

  1. Frequency of Adverse Reactions (ARs)

    Time frame: Week 0- 104

  2. Frequency of Serious Adverse Events (SAEs)

    Time frame: Week 0- 104

  3. Frequency of Serious Adverse Reactions (SARs)

    Time frame: 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

    Time frame: 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

    Time frame: Week 0- 104

  6. Annualised bleeding rate for patients using NovoEight® for preventive regimen

    Time frame: Week 0- 104

  7. Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)

    Time frame: Week 0- 104

  8. Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)

    Time frame: Week 0- 104

  9. Consumption of NovoEight® per month (IU/kg BW/month) for prevention

    Time frame: 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

    Time frame: Week 0- 104

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2014
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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