Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

NCT01586936 | Completed

• 1 other identifier: F7-1949
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Conditions

Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (1)

• Antibody production against eptacog alpha

  Up to 10 years

Study Arms (1)

eptacog alpha users

Drug: eptacog alfa (activated)

Interventions

eptacog alfa (activated) DRUG

Prescription of eptacog alpha at the discretion of the physician

eptacog alpha users

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

Patients from general practice setting who have been deemed appropriate to receive NovoSeven® (eptacog alpha) as new treatment and as part of routine out-patient care by the prescribing physician

You may qualify if:

• Treated with eptacog alpha (NovoSeven®)

You may not qualify if:

• Investigator decision to measure for antibody as unnecessary medical testing

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Factor VII

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 27, 2012
• Study Start: March 10, 1999
• Primary Completion: March 9, 2010
• Study Completion: March 9, 2010
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

JP (1)