A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery (rFVIIa)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
First received: January 19, 2012
Last updated: February 22, 2012
Last verified: February 2012

Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.

Condition Intervention
Hemophilia C
Drug: recombinant factor VIIa

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    End point to be assessed the degree of bleeding following major operation under rFVIIa

Estimated Enrollment: 15
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: recombinant factor VIIa
    single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery
Detailed Description:

Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with severe factor XI deficiency who will give informed consent to participate in the study

Exclusion Criteria:

  • patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
  • Patients who required aorto-coronary bypass or any vascular surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01538160

Contact: Ophira Salomon, MD 97235302104 ophiras@sheba.health.gov.il
Contact: Uri Seligsohn, MD 97235302104 Uri.Seligson@sheba.health.gov.il

Ophira Salomon Not yet recruiting
Ramat -Gan, Israel
Contact: Ophira salomon, MD    01197235302104    ophiras@sheba.health.gov.il   
Contact: Uri Seligsohn, MD    01197235302104    Uri.Seligson@sheba.health.gov.il   
Sub-Investigator: Uri Seligsohn, MD         
Principal Investigator: Ophira Salomon, MD         
Sheba Medical Center
Ramat-Gan, Israel
Sheba Medical Center Enrolling by invitation
Tel Hashomer, Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
  More Information

Salomon et al presented at ASH 2008 entitled

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01538160     History of Changes
Other Study ID Numbers: SHEBA-11-8657-OS-CTIL
Study First Received: January 19, 2012
Last Updated: February 22, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
recombinant factor VIIa
factor XI deficiency

Additional relevant MeSH terms:
Factor XI Deficiency
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on October 13, 2015