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

NCT01701947 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2013-08-23

No results posted yet for this study

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

Interventions

BIOLOGICAL

Hemoleven

Replacement therapy

Sponsors & Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Anne T Neff, MD · Vanderbilt University Medical Center

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701947 on ClinicalTrials.gov