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| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 ( 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 |
|
Factor X Deficiency Hemorrhagic Disorders Blood Coagulation Disorders, Inherited Genetic Diseases, Inborn |
Coagulation Protein Disorders Hematologic Diseases Blood Coagulation Disorders |