EUCTR2009-010722-19-ES
Active, not recruiting
Not Applicable
A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII
ConditionsCongenital Factor XIII deficiencyDeficiencia congénita de factor XIIIMedDRA version: 9.1Level: LLTClassification code 10016083Term: Factor XIII deficiency
DrugsFibrogammin® P
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII
- Sponsor
- CSL Behring LLC
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent/assent for study participation obtained before
- •undergoing any study\-specific procedures.
- •2\. Diagnosed with severe congenital FXIII deficiency (\< 10 U/dL at time of initial
- •diagnosis).
- •3\. Males and females of any age with congenital FXIII deficiency.
- •4\. Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Diagnosis of acquired FXIII deficiency.
- •2\. Administration of a FXIII\-containing product, including blood transfusions or other
- •blood products within 4 weeks prior to the planned Day 0\.
- •3\. Any known congenital or acquired coagulation disorder other than congenital
- •FXIII deficiency.
- •4\. Known or suspected to have antibodies towards FXIII.
- •5\. Use of any other investigational medicinal product within 4 weeks prior to the
- •Baseline Visit (Day 0\).
- •6\. Positive result for human immunodeficiency virus (HIV).
- •7\. Serum aspartate transaminase (AST) or serum alanine transaminase (ALT)
Outcomes
Primary Outcomes
Not specified
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