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

NCT01701947 | Unknown

• 1 other identifier: HM11-1102
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound; Rupture, Surgery, Cesarean Section; Postpartum Hemorrhage; Surgery

Keywords

Factor XI deficiency; EAP; postpartum hemorrhage; surgery; delivery; Child birth

Interventions

Hemoleven BIOLOGICAL

Replacement therapy

Also known as: Human Coagulation Factor XI

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Laboratoire français de Fractionnement et de Biotechnologies: lead

Study Sites (1)

Vanderbilt University Medical Center - Hemostasis & Thrombosis Ctr

Nashville, Tennessee, 37232-5505, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Rupture; Postpartum Hemorrhage; Factor XI Deficiency

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anne T Neff, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Last Updated: August 23, 2013

Record last verified: 2013-08

Locations

US (1)