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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01538160
First received: January 19, 2012
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.

  Eligibility

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

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
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: NCT01538160

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

Locations
Israel
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

No publications provided

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
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 24, 2014