HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency

NO_LONGER_AVAILABLE

Conditions studied: Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery

In brief

The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of administering selectively the missing factor outweigh the potential risks associated with the administration of fresh-frozen plasma.

Key facts

Study ID

NCT01701947

Run by

Laboratoire français de Fractionnement et de Biotechnologies

Last updated by the study team

2013-08-23

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe inherited factor XI deficiency (FXI:C < 0.20 IU/mL i.e. <20 %)
• Patient older than 6 months old and weight at least 8 kg
• Known personal bleeding history
• Patient requiring FXI replacement therapy when oral antifibrinolytic agents alone or other means are ineffective or are contraindicated
• Scheduled to undergo an elective surgical procedure (including caesarean section) for which the patient requires hemostasis prophylaxis, which in the case of caesarean section is due to a history of postpartum bleeding, OR vaginal delivery for which the patient requires hemostasis prophylaxis due to a history of postpartum hemorrhage
• Patient/guardian provides signed and dated Informed Consent for 'HEMOLEVEN Expanded Access Program' prior to entry into the program

You may not qualify if…

• Personal history of thromboembolic events
• Underlying cardiopulmonary disease of NYHA Class III or greater
• History of severe reaction to any component of HEMOLEVEN notably to heparin or to its derivatives,including LMWH. Past history of serious type II heparin-induced thrombocytopenia (HIT)
• Presence of antibody to FXI in the past or currently
• Presence of any other condition that could contraindicate treatment with factor XI concentrate or lead the Physician/Investigator to believe treatment would not be in the best interest of the patient
• Positive, confirmed pregnancy test for patients undergoing elective surgery (not applicable for caesarean section and prevention in vaginal delivery)
• Lactating woman.
• Of the seven exclusion criteria, the first four are included as a precautionary safety measure; the fifth is included to avoid a lack of efficacy.
• The two last criteria are included to minimize confounding influences on the evaluation of patient safety. Oral contraception is not mandatory as a pregnancy test is scheduled at inclusion visit and before surgery.

Where it is running

• Vanderbilt University Medical Center - Hemostasis & Thrombosis Ctr — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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