Status:
COMPLETED
A Study Investigating Treatment Factor X in People With Factor X Deficiency
Lead Sponsor:
Bio Products Laboratory
Conditions:
Factor X Deficiency
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00930176
Start Date
January 1 2010
End Date
November 1 2013
Last Update
December 12 2014
Active Locations (14)
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1
UCSF School of Medicine
San Francisco, California, United States, 94117
2
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
3
Dr. William Mitchell New York Blood Center, Weill Cornell Medical College
New York, New York, United States, 10065
4
Dr Gunter Auerswald
Bremen, Germany