Brief Summary

This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Sep 2002

Shorter than P25 for phase_1

Geographic Reach

5 countries

8 active sites

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

8 months study duration

Study Start

First participant enrolled

September 1, 2002

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed

8.9 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed

Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

March 22, 2012

Last Update Submit

January 11, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B

Outcome Measures

Primary Outcomes (1)

Area under the concentration curve from 0-12 hours

Secondary Outcomes (7)

CL, the total body clearance
Cmax, the maximum concentration
tmax, the time to maximum concentration
t1/2, the terminal half-life
Area under the concentration curve from time 0-infinity
+2 more secondary outcomes

Study Arms (2)

Adults

EXPERIMENTAL

Drug: activated recombinant human factor VII

Paediatric

EXPERIMENTAL

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG

A single bolus dose is administered. Injected intravenously

Adults

Eligibility Criteria

Age3 Years - 55 Years

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

You may not qualify if:

Known hypersensitivity to activated recombinant human factor VII or any of its components
Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
Clinical manifestation of active/recent bleeding
Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
Body Mass Index (BMI) outside normal range
Known abuse of elicit drugs and/or alcohol
Renal insufficiency
Hepatic disease
Cardiovascular disease
Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

Contact the study team to confirm eligibility.