CompletedPhase 2

Human Fibrinogen - Pharmacokinetics

United States15 participantsStarted 2007-07

Plain-language 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.

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Maximum Clot Firmness (MCF)

Timeframe: Pre-infusion and 1 hour post-infusion

Trial details

NCT IDNCT00496262

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2009-05-19

View on ClinicalTrials.gov More Fibrinogen Deficiency trials