Human Fibrinogen - Pharmacokinetics

Completed · Phase 2

Conditions studied: Fibrinogen Deficiency

In brief

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.

Key facts

Study ID

NCT00496262

Run by

CSL Behring

People needed

15

Starts

2007-07-01

Expected to finish

2008-05-01

Last updated by the study team

2016-09-15

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Contact CSL Behring for facility details — Aurora, Colorado, United States
• Contact CSL Behring for facility details — St. Petersburg, Florida, United States
• Contact CSL Behring for facility details — Chicago, Illinois, United States
• Contact CSL Behring for facility details — Scarborough, Maine, United States
• Contact CSL Behring for facility details — New York, New York, United States
• Contact CSL Behring for facility details — Pittsburgh, Pennsylvania, United States
• Contact CSL Behring for facility details — Cagliari, Italy
• Contact CSL Behring for facility details — Florence, Italy
• Contact CSL Behring for facility details — Milan, Italy
• Contact CSL Behring for facility details — Naples, Italy
• Contact CSL Behring for facility details — Padova, Italy
• Contact CSL Behring for facility details — Palermo, Italy
• Contact CSL Behring for facility details — Rome, Italy
• Contact CSL Behring for facility details — Sassari, Italy
• Contact CSL Behring for facility details — Vicenza, Italy

Full record on ClinicalTrials.gov

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