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

NCT02207218 | Completed

• 2 other identifiers: NN7008-4105U1111-1144-8212
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Congenital Bleeding Disorder; Haemophilia A

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events (AEs)

  Week 0- 104

Secondary Outcomes (10)

• Frequency of Adverse Reactions (ARs)

  Week 0- 104

• Frequency of Serious Adverse Events (SAEs)

  Week 0- 104

• Frequency of Serious Adverse Reactions (SARs)

  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

  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

  Week 0- 104

Study Arms (1)

NovoEight®

Drug: turoctocog alfa

Interventions

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.

NovoEight®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Suginami-ku, Tokyo, 1670035, Japan

Location

Novo Nordisk Investigational Site

Tokyo, 167-0035, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII N8

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Global Clinical Registry GCR, 1452

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 4, 2014
• Study Start: August 4, 2014
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

JP (2)