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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01561391
First received: March 21, 2012
Last updated: December 5, 2012
Last verified: December 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: No ]
  • Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Designated as safety issue: No ]
  • Changes in coagulation-related parameters [ Designated as safety issue: No ]

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

Ages Eligible for Study:   5 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561391

Locations
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60611
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Rochester, Minnesota, United States, 55905
United States, New Mexico
Novo Nordisk Clinical Trial Call Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10029-6574
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michael Sumner, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01561391     History of Changes
Other Study ID Numbers: F7HAEM/USA/4/USA
Study First Received: March 21, 2012
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014