Human Fibrinogen - Pharmacokinetics - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00496262

Purpose

A pharmacokinetic study (prospective, open, uncontrolled study in twelve evaluable subjects) with "clot strength" as surrogate endpoint to demonstrate hemostatic efficacy. Clot strength will be determined using thromboelastography (TEG). TEG has been used for detecting and managing various bleeding disorders as it has been demonstrated to be a predictive marker for clinical coagulopathy.

Condition	Intervention	Phase
Congenital Fibrinogen Deficiency	Drug: Human Fibrinogen	Phase II

Genetics Home Reference related topics: hemophilia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetics of Human Fibrinogen in Subjects With Congenital Fibrinogen Deficiency

Further study details as provided by CSL Behring:

Primary Outcome Measures:

To compare maximum clot strength (MCF) as a surrogate marker for hemostatic efficacy before and after administration of Human Fibrinogen [ Time Frame: two times during study ] [ Designated as safety issue: No ]
To demonstrate that MCF 1 hour after administration of 70 mg/kg b.w. of Human Fibrinogen is significantly higher compared to baseline [ Time Frame: two times during study ] [ Designated as safety issue: No ]
To determine the single dose pharmacokinetics of Human Fibrinogen in subjects with congenital fibrinogen deficiency [ Time Frame: within the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety of Human Fibrinogen in subjects with congenital fibrinogen deficiency [ Time Frame: from day 1 to day 45 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	June 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Single intravenous infusion of 70 mg/kg body weight

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged ≥ 6 years
Documented congenital fibrinogen deficiency:
Fibrinogen deficiency manifested as afibrinogenemia
Plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
Informed consent signed by subject or legal guardian

Exclusion Criteria:

Presence or history of:
Hypersensitivity to Human Fibrinogen
Deep vein thrombosis or pulmonary embolism
Arterial thrombosis
Hypersensitivity to human plasma proteins
Acute bleeding· History of esophageal varicose bleeding
End stage liver disease (i.e. Child Pugh score B or C)
Planned major surgery with a need for blood transfusion during the PK blood sampling period of this study
Polytrauma 1 year prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496262

Locations

United States, Colorado

Aurora, Colorado, United States, 80450-0507

Sponsors and Collaborators

CSL Behring

More Information

Responsible Party:	CSL Behring GmbH ( Sigurd Knaub, PhD / Study Director )
Study ID Numbers:	BI3023_2001
Study First Received:	July 3, 2007
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00496262
Health Authority:	United States: Food and Drug Administration; Italy: Ministry of Health

Keywords provided by CSL Behring:

Congenital fibrinogen deficiency
Fibrinogen concentrate
Pharmacokinetics
Thrombelastography

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Afibrinogenemia
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 16, 2009