Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND

Conditions: PK study in patient with afibrinogemia
MedDRA version: 9.1Level: LLTClassification code 10016075Term: Factor I deficiency

Registration Number: EUCTR2006-006023-39-IT

Lead Sponsor: CSL Behring GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Aged =>6 years

Documented congenital fibrinogen deficiency

- Fibrinogen deficiency manifested as afibrinogemia

-Plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)

Informed consent signed by subject or legal guardian
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>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.<br><br>To detrmine the single dose pharmakinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency

Secondary Outcome Measures