Clinical Trial of Factor XIII (FXIII) Concentrate
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/9/2018 |
| Start Date: | January 2000 |
| End Date: | December 2011 |
Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency
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.
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.
Inclusion Criteria:
- Patients may be of either sex or age. Children and newborn infants are specifically
included in this study.
- Patient must have documented congenital Factor XIII deficiency
- Patient or legal guardian must sign informed consent
- Patients who have negative serology for hepatitis B should receive Hepatitis B
vaccination.
Exclusion Criteria:
- Patient has acquired Factor XIII deficiency
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