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Completed

NCT Number: NCT01561391

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 surgical procedures.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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

factor IX

Other

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

factor VIII

Drug

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

Primary outcomes

  1. Presence and maintenance of haemostasis

  2. Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII

Secondary outcomes

  1. Adverse Events

  2. Changes in coagulation-related parameters

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Mar 23, 2012
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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