NCT00853086

Brief Summary

This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

3.4 years

First QC Date

February 27, 2009

Last Update Submit

November 15, 2016

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia B

Outcome Measures

Primary Outcomes (1)

  • Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes.

    Assessments at 6 month intervals

Study Arms (1)

A

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG

Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice

Also known as: NovoSeven®, rFVIIa, F7
A

Eligibility Criteria

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

Patients from speciality practice settings

You may qualify if:

  • All haemophilia A or B patients with inhibitors treated with NovoSeven are included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

GB(1)