NCT00571584|CompletedPhase 4

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7HEAM-1510

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredDec 2007

StartedNov 2002

CompletionMar 2004

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Nov 2002

Geographic Reach

7 countries

18 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

1.3 years study duration

Study Start

First participant enrolled

November 1, 2002

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed

3.8 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed

Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

December 11, 2007

Last Update Submit

January 11, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (1)

Global treatment response of the patient by an algorithm based pain and joint mobility assessments

Secondary Outcomes (4)

Pain assessment
Mobility assessment
Circumference of joint
Adverse events

Interventions

activated recombinant human factor VIIDRUG

Eligibility Criteria

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
A history of 3 or more joint bleeds during the last 12 months

You may not qualify if:

Joint bleeding within 7 days prior to trial start
Treatment for bleeds within the last 5 days prior to trial start
Clinically relevant coagulation disorders other than congenital haemophilia A or B

Contact the study team to confirm eligibility.