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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01561391

Enrollment

Registered

2012-03-23

Start date

1998-04-30

Completion date

2004-05-31

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

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.

Interventions

DRUGactivated recombinant human factor VII

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

OTHERfactor IX

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

DRUGfactor VIII

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse Events	—
Changes in coagulation-related parameters	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026