A Study Investigating Treatment Factor X in People With Factor X Deficiency
NCT ID: NCT00930176
Last Updated: 2014-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
16 participants
INTERVENTIONAL
2010-01-31
2013-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Human Coagulation FACTOR X
Human Coagulation FACTOR X
Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
Interventions
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Human Coagulation FACTOR X
Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Years
ALL
No
Sponsors
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Bio Products Laboratory
OTHER
Responsible Party
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Principal Investigators
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Amy Shapiro, Dr
Role: PRINCIPAL_INVESTIGATOR
Co-Medical Director, Indiana Hemophilia and Thrombosis Center, 8402 Harcourt Road, Suite 420, Indianapolis, IN46260, USA
Locations
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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
Countries
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References
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Oner AF, Celkan T, Timur C, Norton M, Kavakli K. Use of a High-Purity Factor X Concentrate in Turkish Subjects with Hereditary Factor X Deficiency: Post Hoc Cohort Subanalysis of a Phase 3 Study. Turk J Haematol. 2018 May 25;35(2):129-133. doi: 10.4274/tjh.2017.0446. Epub 2018 Mar 16.
Other Identifiers
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Ten01
Identifier Type: -
Identifier Source: org_study_id