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COMPLETEDPhase 4NCT01561391

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

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 sur...

Lead sponsor: Novo Nordisk A/S•14 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novo Nordisk A/S

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 29, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment36

Start dateApr 1998

Last updatedDec 29, 2023

Condition

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Locations shown

Novo Nordisk Investigational Site

Los Angeles, California

Novo Nordisk Investigational Site

Chicago, Illinois

Novo Nordisk Investigational Site

Chicago, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2023Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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