Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery

Stopped early · Phase 3

Conditions studied: Factor X Deficiency

In brief

To primary efficacy variable is to assess the presence or absence of excessive blood loss during and after surgery. The secondary efficacy endpoints are as follows: 1. A subjective overall assessment by the investigator of FACTOR X in the control of bleeding during surgery. 2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is at risk of post-operative bleeding, including location and duration. 3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion. 4. Assessment of FX:C and FX:Ag levels on each day post-surgery. 5. Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C (IU/kg body weight) administered to each subject to maintain haemostasis. 6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to each subject to maintain haemostasis. 7. Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered daily (day of surgery and each post-operative day) to maintain haemostasis.

Key facts

Study ID: NCT01086852
Run by: Bio Products Laboratory
People needed: 4
Starts: 2011-03-01
Expected to finish: 2014-01-01
Last updated by the study team: 2019-02-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects who are at least 12 years of age at date of written informed consent/assent.
Subjects who have given written informed consent or, for subjects aged 12-17 years (inclusive), have given written assent and whose parent/guardian has given written informed consent.
Subjects with hereditary mild to severe Factor X deficiency (<20% basal FX activity), including previously untreated subjects OR those currently treated with Fresh Frozen Plasma (FFP), Prothrombin Complex Concentrate (PCC) or factor IX/X concentrate by prophylaxis or on demand.
Subjects who are to undergo surgery in which the investigator believes a factor X concentrate will be required due to a prior history of unusual bleeding either spontaneously or after surgery or trauma in the absence of treatment with a factor X containing product.
Pregnant subjects undergoing obstetric delivery (including Caesarean surgery and vaginal delivery) may enter the study. Female subjects of child-bearing potential must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female subject is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.

You may not qualify if…

Subjects who are required or expected to take other factor X containing medications during or after surgery.
Subjects with a history of inhibitor development to FX or a detectable inhibitor to FX (≥0.6 BU) on the Nijmegen-Bethesda assay at screening. Obtaining a FX inhibitor result at screening is not mandatory if the subject is to undergo emergency surgery and the local laboratory is unable to perform the analyses prior to the surgical procedure.
Subjects with thrombocytopenia (platelets < 50 x 109/L).
Subjects who have clinically significant renal disease (creatinine >200µmol/L).
Subjects who have clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
Subjects known to have other coagulopathy or thrombophilia.
Subjects who are currently participating or have participated in another trial within the last 30 days, with the exception of the BPL Factor X PK study (protocol number Ten01).
Female subjects who are lactating.
Subjects who have known or suspected hypersensitivity to the investigational medicinal product or its excipients.
Subjects known to have abused chemicals or drugs within the past 12 months.
Subjects with a history of unreliability or non-cooperation.

Where it is running

University Of Texas Health Science Center, Gulf States Hemophilia and Thrombophilia Center 6655 Travis St — Houston, Texas, United States
Unidad Coagulopatías, Congenitas, Edificio Dotacional, 1ra Planta Hospital Universito La Paz — Madrid, Spain
Ege University School of Medicine, Departmant of Pediatric Hematology — Bornova, İzmir, Turkey (Türkiye)
Istanbul University Cerrahpasa Medicine Faculty Department of Pediatric Hematology — Istanbul, Turkey (Türkiye)
Department of Hematology, Royal Cornwall Hospital, — Truro, Cornwall, United Kingdom
The Katherine Dormandy Haemophilia Centre and Thrombosis Unit, The Royal Free Hospital,Pond Street — Hampstead, London, United Kingdom
Hammersmith Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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