Human Fibrinogen – Pharmacokinetics

Brief Title

Human Fibrinogen - Pharmacokinetics

Official Title

Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

Brief Summary

      This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and
      clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen
      deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen
      when a fixed dose of human fibrinogen concentrate was administered.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Maximum Clot Firmness (MCF)

Secondary Outcome

 Terminal Elimination Half-life (t1/2)

Condition

Fibrinogen Deficiency

Intervention

Human Fibrinogen Concentrate

Study Arms / Comparison Groups

 Human Fibrinogen Concentrate
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

15

Start Date

July 2007

Completion Date

May 2008

Primary Completion Date

May 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Aged ≥ 6 years

          -  Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as
             afibrinogenemia with 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 Concentrate or human
             plasma proteins,

          -  Presence or history of deep vein thrombosis, pulmonary embolism, or arterial
             thrombosis

          -  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

          -  Polytrauma within 1 year prior to enrollment
      

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Program Director, Clinical R&D, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00496262

Organization ID

BI3023_2001


Responsible Party

Sponsor

Study Sponsor

CSL Behring


Study Sponsor

Program Director, Clinical R&D, Study Director, CSL Behring


Verification Date

February 2011