NCT01285089

Brief Summary

This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Typical duration 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

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

January 26, 2011

Last Update Submit

January 29, 2014

Conditions

Acquired Bleeding DisorderAcquired Haemophilia

Outcome Measures

Primary Outcomes (1)

  • Identification of decision criteria to treat patient with activated recombinant human factor VII

    Year 3

Secondary Outcomes (1)

  • Number of patients with a control of bleeding

    Year 3

Study Arms (1)

A

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG

Data collection of the use of activated recombinant human factor VII observed through real-world treatment practices

A

Eligibility Criteria

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

Any patient diagnosed with acquired haemophilia and treated with at least one injection of activated recombinant human factor VII can be included in the study. The treatment will be performed according the local practice.

You may qualify if:

  • Diagnosed with acquired haemophilia
  • Treated with activated recombinant human factor VII as first line treatment
  • Treated with activated recombinant human factor VII after January 2011

You may not qualify if:

  • Patients with first diagnosis before january 2010 and having a relapse after january 2011
  • Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris La Défense Cedex, 92932, France

Location

Related Links

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

January 26, 2011

First Posted

January 27, 2011

Study Start

December 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

FR(1)