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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2006-006023-39-IT |
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Date of registration:
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12/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND
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Scientific title:
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Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND |
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Date of first enrolment:
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24/09/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006023-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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PK study in patient with afibrinogemia
MedDRA version: 9.1
Level: LLT
Classification code 10016075
Term: Factor I deficiency
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Intervention(s)
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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
Concentration number: 1-
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Primary Outcome(s)
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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
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Primary end point(s): Surrogate end point for hemostatic efficacy
MCF (primary analisys made 1 hour post infusion)
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Secondary Objective: To assess the safety pf Haemocomplettan P in subjects with congenital fibrinogen deficiency
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Secondary ID(s)
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BI 3023_2001
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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