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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

Page last updated: August 23, 2015

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