NCT01579955

Brief Summary

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 1999

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

11 years

First QC Date

April 11, 2012

Last Update Submit

February 22, 2017

Conditions

Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

  • Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective

    Year 1

  • Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective

    Year 10

Secondary Outcomes (1)

  • Number of adverse events (AEs), including serious adverse events (SAEs)

    Baseline, every 1 year, Year 10

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha)

You may qualify if:

  • Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment

You may not qualify if:

  • Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Interventions

Factor VII

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

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

April 11, 2012

First Posted

April 18, 2012

Study Start

March 10, 1999

Primary Completion

March 9, 2010

Study Completion

March 9, 2010

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

JP(1)