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Sponsored by: |
CSL Behring |
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Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00496262 |
A pharmacokinetic study (prospective, open, uncontrolled study in twelve evaluable subjects) with "clot strength" as surrogate endpoint to demonstrate hemostatic efficacy. Clot strength will be determined using thromboelastography (TEG). TEG has been used for detecting and managing various bleeding disorders as it has been demonstrated to be a predictive marker for clinical coagulopathy.
Condition | Intervention | Phase |
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Congenital Fibrinogen Deficiency |
Drug: Human Fibrinogen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics of Human Fibrinogen in Subjects With Congenital Fibrinogen Deficiency |
Estimated Enrollment: | 15 |
Study Start Date: | June 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CSL Behring GmbH ( Sigurd Knaub, PhD / Study Director ) |
Study ID Numbers: | BI3023_2001 |
Study First Received: | July 3, 2007 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00496262 |
Health Authority: | United States: Food and Drug Administration; Italy: Ministry of Health |
Congenital fibrinogen deficiency Fibrinogen concentrate Pharmacokinetics Thrombelastography |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Coagulation Disorders Afibrinogenemia Hemostatic Disorders |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |