Clinical trial NCT00496262: Human Fibrinogen - Pharmacokinetics
Official title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrinogen Deficiency
Keywords: Congenital fibrinogen deficiency
Fibrinogen concentrate
Pharmacokinetics
Thrombelastography
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum Clot Firmness (MCF)
timeFrame: Pre-infusion and 1 hour post-infusion
Secondary outcomes:
measure: Terminal Elimination Half-life (t1/2)
timeFrame: 0.5 hours to 13 days post-infusion
measure: Maximum Concentration (Cmax)
timeFrame: Pre-infusion to 13 days post-infusion
measure: Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose
timeFrame: Pre-infusion to 13 days post-infusion
measure: Clearance (Cl)
timeFrame: Pre-infusion to 13 days post-infusion
measure: Mean Residence Time (MRT)
timeFrame: Pre-infusion to 13 days post-infusion
measure: Volume of Distribution at Steady State (Vss)
timeFrame: Pre-infusion to 13 days post-infusion
measure: Incremental In Vivo Recovery (IVR)
timeFrame: Pre-infusion to 4 hours post-infusion
measure: Classical In Vivo Recovery (IVR)
timeFrame: Pre-infusion to 4 hours post-infusion
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Contact CSL Behring for facility details
state: Colorado
city: St. Petersburg
country: United States
facility: Contact CSL Behring for facility details
state: Florida
city: Chicago
country: United States
facility: Contact CSL Behring for facility details
state: Illinois
city: Scarborough
country: United States
facility: Contact CSL Behring for facility details
state: Maine
city: New York
country: United States
facility: Contact CSL Behring for facility details
state: New York
city: Pittsburgh
country: United States
facility: Contact CSL Behring for facility details
state: Pennsylvania
city: Cagliari
country: Italy
facility: Contact CSL Behring for facility details
city: Firenze
country: Italy
facility: Contact CSL Behring for facility details
city: Milano
country: Italy
facility: Contact CSL Behring for facility details
city: Napoli
country: Italy
facility: Contact CSL Behring for facility details
city: Padova
country: Italy
facility: Contact CSL Behring for facility details
city: Palermo
country: Italy
facility: Contact CSL Behring for facility details
city: Rome
country: Italy
facility: Contact CSL Behring for facility details
city: Sassari
country: Italy
facility: Contact CSL Behring for facility details
city: Vicenza
country: Italy
facility: Contact CSL Behring for facility details
Study officials:
affiliation: CSL Behring
name: Program Director, Clinical R&D
role: STUDY_DIRECTOR
References:
citation: Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P; FIBRINOGEN CONCENTRATE STUDY GROUP. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009 Dec;7(12):2064-9. doi: 10.1111/j.1538-7836.2009.03633.x. Epub 2009 Oct 5.