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Sponsors and Collaborators: |
Children’s Hospital of Orange County CSL Behring |
Information provided by: | Children’s Hospital of Orange County |
ClinicalTrials.gov Identifier: | NCT00640289 |
Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be useful for prevention and treatment of bleeding episodes, especially of spontaneous intracranial bleedings. In this study, Fibrogammin P will be given to patients with congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor XIII administration will be determined by the factor's circulating half-life. During the first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week period. Safety data will include accrual of information on viral safety, liver function, complete blood counts and adverse events. Historical data concerning spontaneous bleeds will be collected whenever possible two years prior to treatment with Fibrogammin P.
Condition | Intervention |
Hemophilia Factor XIII Deficiency |
Drug: Fibrogammin P |
Genetics Home Reference related topics: | hemophilia |
ChemIDplus related topics: | Fibrinolysin, human |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency |
Estimated Enrollment: | 80 |
Study Start Date: | January 2000 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Treatment
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Drug: Fibrogammin P
Prophylaxis treatment
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diane J. Nugent, MD | 714-532-8744 | djn0@choc.org |
Contact: Kathie J. Birschbach | 714-532-8777 | kjb0@choc.org |
United States, California | |||||
Children's Hospital of Orange Co. | Recruiting | ||||
Orange, California, United States, 92868 | |||||
Contact: Diane J. Nugent, MD 714-532-8744 djn0@choc.org | |||||
Contact: Kathie J. Birschbach, MD 714-532-8744 kjb0@choc.org |
Children’s Hospital of Orange County |
CSL Behring |
Principal Investigator: | Diane J. Nugent, MD | Children's Hospital of Orange Co. |
Responsible Party: | Director of Hematology at Childrens Hospitl of Orange County ( Diane Nugent, MD ) |
Study ID Numbers: | BB-IND5986 |
First Received: | March 17, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00640289 |
Health Authority: | United States: Food and Drug Administration |
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