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A Study Investigating Treatment Factor X in People With Factor X Deficiency
This study is not yet open for participant recruitment.
Verified by Bio Products Laboratory, November 2009
First Received: June 10, 2009   Last Updated: November 9, 2009   History of Changes
Sponsor: Bio Products Laboratory
Information provided by: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT00930176
  Purpose

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.


Condition Intervention Phase
Factor X Deficiency
Biological: Human Coagulation FACTOR X
Phase III

Study Type: Interventional
Official Title: A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.

Resource links provided by NLM:


Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:
  • Pharmacokinetic parameters for FACTOR X:Concentrate at the Baseline Visit and the repeat Pharmacokinetic assessment (usually at the 6 month visit) [ Time Frame: maximum study duration of study treatment (excluding the screening period) for each subject is 2 years. ]

Study Start Date: January 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930176

Contacts
Contact: Ellen Spellman, Dr +44 (0)208 258 2349 ellen.spellman@bpl.co.uk
Contact: Miranda Norton, Dr +44 (0)208 258 2661 miranda.norton@bpl.co.uk

Sponsors and Collaborators
Bio Products Laboratory
Investigators
Principal Investigator: Amy Shapiro, Dr Co-Medical Director, Indiana Hemophilia and Thrombosis Center, 8402 Harcourt Road, Suite 420, Indianapolis, IN46260, USA
  More Information

No publications provided

Responsible Party: Bio Products Laboratory ( Dr. Clive Dash )
Study ID Numbers: Ten01
Study First Received: June 10, 2009
Last Updated: November 9, 2009
ClinicalTrials.gov Identifier: NCT00930176     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Factor X Deficiency
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders

ClinicalTrials.gov processed this record on February 08, 2010