A Study Investigating Treatment Factor X in People With Factor X Deficiency
Completed · Phase 3
Conditions studied: Factor X Deficiency
In brief
The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg. The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
Key facts
- Study ID
- NCT00930176
- Run by
- Bio Products Laboratory
- People needed
- 16
- Starts
- 2010-01-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2014-12-12
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent given, or for subjects aged 12-17 years, have given written assent and whose parent/guardian has given written informed consent
- At least 12 years of age at dtae of written informed consent
- Have hereditary severe or moderate FX deficiency
- Currently treated with Fresh Frozen Plasma FFP, Prothrombin Complex Concentrate PCC or factor IX/X concentrate
- Must have a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment of FFP, PCC or factor IX/X concentrate. Newly diagnosed subjects who present at the hospital with a bleed may be included
- Must have had at least 7 days, and ideally 10-14 days, since an infusion of either FFP, PCC or factor IX/X concentrate at Baseline Visit
- Females of child bearing potential must have a negative result on a HCG based pregnancy test. If they are or become sexually active, they must practise contraception by using a method of proven reliability for the duration of the study
You may not qualify if…
- Have a history of inhibitor development to FX or a positive result at the Screening Visit
- Bleeding at the appointment for the PK assessment
- Subjects who have thrombocytopenia
- Have clinically significant liver disease
- Known to have other coagulopathy or thrombophilia
- Have known or suspected hypersensitivity to the investigational medicinal product or its excipients
- Have abused chemicals or drugs within the past 12 months
- Have a history of unreliability or non-cooperation
- Participating or have taken part in another trial within the last 30 days, with the exception of BPL FX surgery study - Protocol Ten03. In such cases, subjects should have completed their End of Study Visit either before or on the day of Screening Visit for this study
- Female subjects who are pregnant or lactating
- Subjects planning greater than 4 weeks absence from the locality of the Investigational site, between the screening visit and the repeat PK assessment
Where it is running
- UCSF School of Medicine — San Francisco, California, United States
- Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States
- Dr. William Mitchell New York Blood Center, Weill Cornell Medical College — New York, New York, United States
- Dr Gunter Auerswald — Bremen, Germany
- Dr. Bermejo — Cáceres, Spain
- Dr Maite Alvarez — Madrid, Spain
- Cukurova University Hospital — Balcali, Adana, Turkey (Türkiye)
- Ministry of Health Istanbul Goztepe Training & Research Hospital — Göztepe, Istanbul, Turkey (Türkiye)
- Istanbul University Cerrahpasa School of Medicine — Istanbul, Turkey (Türkiye)
- Kanuni Sultan Suleyman Training and Research Hospital — Istanbul, Turkey (Türkiye)
- Prof. Kavakli — Izmir, Turkey (Türkiye)
- Prof. Oner — Van, Turkey (Türkiye)
- Dr. Sue Pavord — Leicester, United Kingdom
- Dr. Steve Austin — London, United Kingdom
Full record on ClinicalTrials.gov
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