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NCT01701947: EAP
HEMOLEVEN® Expanded Access Program for Prevention of Surgical and Postpartum Hemorrhage in Patients With Severe Inherited Factor XI Deficiency
trial testing Hemoleven in Wound; Rupture, Surgery, Cesarean Section. No longer available.
Quick facts
| Lead sponsor | Laboratoire français de Fractionnement et de Biotechnologies |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hemoleven — full drug profile →
Conditions studied
- Wound; Rupture, Surgery, Cesarean Section — all drugs for Wound; Rupture, Surgery, Cesarean Section →
- Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →
- Surgery — all drugs for Surgery →
Sponsor
Laboratoire français de Fractionnement et de Biotechnologies — full company profile →
Who can join
6 Months and older, any sex, with Wound; Rupture, Surgery, Cesarean Section or Postpartum Hemorrhage.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01701947
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other Laboratoire français de Fractionnement et de Biotechnologies trials
Trials by the same sponsor.
- NCT05695391 — A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Blee · Phase 3 · terminated
- NCT05904210 — Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® · completed
- NCT02548143 — LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures · Phase 3 · completed
- NCT02448680 — A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa · Phase 3 · completed
- NCT02155725 — Fibrinogen in Haemorrhage of Delivery · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01701947 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laboratoire français de Fractionnement et de Biotechnologies
- Last refreshed: 22 August 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01701947.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing