N/A
Completed N=72
Clinical Trial of Factor XIII (FXIII) Concentrate
Hemophilia · Factor XIII Deficiency
Source: ClinicalTrials.gov NCT00640289 ↗
Enrolled (actual)
72
Serious AEs
11.1%
Results posted
Nov 2018
Primary outcomePrimary: Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions — 30; 1; 0; 3 Number of bleeds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions |
30; 1; 0; 3 | — |
| SECONDARY Surgical Efficacy Assessments With Factor XIII |
15; 0; 0; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00640289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.