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

December 27, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novo Nordisk Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10029-6574
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7220
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous infusion
Drug: activated recombinant human factor VII
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
Drug: activated recombinant human factor VII
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
Experimental: Bolus injection
Drug: activated recombinant human factor VII
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
Drug: activated recombinant human factor VII
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
Experimental: Control
Other: factor 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.
Drug: factor 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Adverse Events
Changes in coagulation-related parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimated)

March 23, 2012

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM/USA/4/USA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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