Human Fibrinogen - Pharmacokinetics
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibrinogen Deficiency
Intervention: Human Fibrinogen Concentrate (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s): Program Director, Clinical R&D, Study Director, Affiliation: CSL Behring
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.
Clinical Details
Official title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum Clot Firmness (MCF)
Secondary outcome: Terminal Elimination Half-life (t1/2)Maximum Concentration (Cmax) Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose Clearance (Cl) Mean Residence Time (MRT) Volume of Distribution at Steady State (Vss) Incremental In Vivo Recovery (IVR) Classical In Vivo Recovery (IVR)
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Contact CSL Behring for facility details, Cagliari 09100, Italy
Contact CSL Behring for facility details, Firenze 50134, Italy
Contact CSL Behring for facility details, Milano 20122, Italy
Contact CSL Behring for facility details, Napoli 80122, Italy
Contact CSL Behring for facility details, Padova 35128, Italy
Contact CSL Behring for facility details, Palermo 90134, Italy
Contact CSL Behring for facility details, Rome 00161, Italy
Contact CSL Behring for facility details, Sassari 07100, Italy
Contact CSL Behring for facility details, Vicenza 36100, Italy
Contact CSL Behring for facility details, Aurora, Colorado 80045, United States
Contact CSL Behring for facility details, St. Petersburg, Florida 33701, United States
Contact CSL Behring for facility details, Chicago, Illinois 60614, United States
Contact CSL Behring for facility details, Scarborough, Maine 04074-9308, United States
Contact CSL Behring for facility details, New York, New York 10021, United States
Contact CSL Behring for facility details, Pittsburgh, Pennsylvania 15232, United States
Additional Information
Click here to request more information about this study
Starting date: July 2007
Last updated: September 21, 2011
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