PK study in patient with afibrinogemia MedDRA version: 9.1 Level: LLT Classification code 10016075 Term: Factor I deficiency
Conditions
Interventions
Trade Name: Haemocomplettan P
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: Factor I
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
CSL Behring GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged =>6 years Documented congenital fibrinogen deficiency - Fibrinogen deficiency manifested as afibrinogemia -Plasma fibrinogen activity and antigen at screening undetectable (i.e. =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Life expectancy < 6 months Bledding disorder other than congenital fibrinogen deficiency Treatment with any AMP, other Haemocomplettan P, in the 4 weeks prior to enrollment HIV positive Polytrauma in the 2 years prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety pf Haemocomplettan P in subjects with congenital fibrinogen deficiency;Primary end point(s): Surrogate end point for hemostatic efficacy MCF (primary analisys made 1 hour post infusion);Main Objective: To compare maximum cloth strength (MCF) as a surrogate marker for hemostatic efficacy before and after administration of Haemocomplettan P in subjects with congenital fibrinogen deficiency and to demonstrate that MCF 1 hour after administration of 70 mg/kg b.w. of Haemocomplettan P is significantly higher comparated to baseline. To detrmine the single dose pharmakinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency | — |
Countries
Italy
Outcome results
None listed