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| Sponsor: | Bio Products Laboratory |
|---|---|
| Information provided by (Responsible Party): | 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 |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kate Gillanders, Mrs | +44 (0)208 957 2562 | kate.gillanders@bpl.co.uk |
| Contact: Miranda Norton, Dr | +44 (0)208 957 2661 | miranda.norton@bpl.co.uk |
| United States, Indiana | |
| Indiana Hemophilia & Thrombosis Center | Not yet recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Amy Shapiro, MD | |
| Principal Investigator: Amy Shapiro, MD | |
| United States, New York | |
| Dr. William Mitchell New York Blood Center, Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Mitchell 212-570-3280 frh2005@med.cornell.edu | |
| Germany | |
| Dr Gunter Auerswald | Recruiting |
| Bremen, Germany | |
| Spain | |
| Dr. Bermejo | Recruiting |
| Caceres, Spain | |
| Dr Maite Alvarez | Recruiting |
| Madrid, Spain | |
| Turkey | |
| Prof. Kavakli | Recruiting |
| Izmir, Turkey | |
| Prof. Oner | Recruiting |
| Van, Turkey | |
| United Kingdom | |
| Dr. Sue Pavord | Recruiting |
| Leicester, United Kingdom | |
| Dr. Steve Austin | Recruiting |
| London, United Kingdom | |
| Dr. Mike Makris | Not yet recruiting |
| Sheffield, United Kingdom | |
| Principal Investigator: | Amy Shapiro, Dr | Co-Medical Director, Indiana Hemophilia and Thrombosis Center, 8402 Harcourt Road, Suite 420, Indianapolis, IN46260, USA |
More Information
| Responsible Party: | Bio Products Laboratory |
| ClinicalTrials.gov Identifier: | NCT00930176 History of Changes |
| Other Study ID Numbers: | Ten01 |
| Study First Received: | June 10, 2009 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Factor X Deficiency Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |