NCT01561391|CompletedPhase 4

Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7HAEM/USA/4/USA

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2012

StartedApr 1998

CompletionMay 2004

Brief Summary

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

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 Apr 1998

Longer than P75 for phase_4

Geographic Reach

1 country

14 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

6.1 years study duration

Study Start

First participant enrolled

April 1, 1998

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed

7.9 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed

Last Updated

December 29, 2023

Status Verified

January 1, 2017

Enrollment Period

6.1 years

First QC Date

March 21, 2012

Last Update Submit

December 27, 2023

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII

Secondary Outcomes (2)

Adverse Events
Changes in coagulation-related parameters

Study Arms (3)

Continuous infusion

EXPERIMENTAL

Drug: activated recombinant human factor VII

Bolus injection

EXPERIMENTAL

Drug: activated recombinant human factor VII

Control

EXPERIMENTAL

Other: factor IXDrug: factor VIII

Interventions

activated recombinant human factor VIIDRUG

Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.

Continuous infusion

factor IXOTHER

Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.

Control

factor VIIIDRUG

Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.

Control

Eligibility Criteria

Age5 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
Require pre-planned major surgery in hospital

You may not qualify if:

Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
Have any haemostatic disorder other than haemophilia

Contact the study team to confirm eligibility.