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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561391
First Posted: March 23, 2012
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors Drug: activated recombinant human factor VII Other: factor IX Drug: factor VIII Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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:
  • Adverse Events
  • Changes in coagulation-related parameters

Enrollment: 36
Study Start Date: April 1998
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: Bolus injection 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561391


Locations
United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60612
United States, Louisiana
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
United States, Minnesota
Novo Nordisk Investigational Site
Rochester, Minnesota, United States, 55905
United States, New Jersey
Novo Nordisk Investigational Site
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
Novo Nordisk Investigational Site
New York, New York, United States, 10029-6574
United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7220
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561391     History of Changes
Other Study ID Numbers: F7HAEM/USA/4/USA
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: January 12, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases
Hemophilia A
Hemophilia B
Factor VIII
Coagulants