NCT00640289

Clinical Trial of Factor XIII (FXIII) Concentrate

Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Children's Hospital of Orange County · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemophilia
• Factor XIII Deficiency

Interventions

Type	Name	Description
DRUG	Fibrogammin P	Prophylaxis treatment

Timeline

• Start date: 2000-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-03-21
• Last updated: 2018-11-07
• Results posted: 2018-11-07

Locations

1 site across 1 country: United States