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

Hemophilia C Clinical Trial

— rFVIIa  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01538160
• Other study ID #: SHEBA-11-8657-OS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2012
• Last updated: February 22, 2012
• Start date: February 2012
• Est. completion date: July 2015

Study information

• Verified date: February 2012
• Source: Sheba Medical Center
• Contact: Ophira Salomon, MD
• Phone: 97235302104
• Email: ophiras[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Factor XI Deficiency
• Hemophilia C

Intervention

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

Locations

Country	Name	City	State
Israel	Ophira Salomon	Ramat -Gan
Israel	Sheba Medical Center	Ramat-Gan
Israel	Sheba Medical Center	Tel Hashomer, Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Salomon et al presented at ASH 2008 entitled

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency	End point to be assessed the degree of bleeding following major operation under rFVIIa	1 week	No