Human Fibrinogen - Pharmacokinetics

July 27, 2016 updated by: CSL Behring

Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cagliari, Italy, 09100
        • Contact CSL Behring for facility details
      • Firenze, Italy, 50134
        • Contact CSL Behring for facility details
      • Milano, Italy, 20122
        • Contact CSL Behring for facility details
      • Napoli, Italy, 80122
        • Contact CSL Behring for facility details
      • Padova, Italy, 35128
        • Contact CSL Behring for facility details
      • Palermo, Italy, 90134
        • Contact CSL Behring for facility details
      • Rome, Italy, 00161
        • Contact CSL Behring for facility details
      • Sassari, Italy, 07100
        • Contact CSL Behring for facility details
      • Vicenza, Italy, 36100
        • Contact CSL Behring for facility details
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Contact CSL Behring for facility details
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Contact CSL Behring for facility details
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Contact CSL Behring for facility details
    • Maine
      • Scarborough, Maine, United States, 04074-9308
        • Contact CSL Behring for facility details
    • New York
      • New York, New York, United States, 10021
        • Contact CSL Behring for facility details
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Contact CSL Behring for facility details

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Human Fibrinogen Concentrate
Biological: Human Fibrinogen Concentrate
Single intravenous infusion of 70 mg/kg body weight
Other Names:
  • Haemocomplettan® P
  • RiaSTAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Clot Firmness (MCF)
Time Frame: Pre-infusion and 1 hour post-infusion
MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.
Pre-infusion and 1 hour post-infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Terminal Elimination Half-life (t1/2)
Time Frame: 0.5 hours to 13 days post-infusion
t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
0.5 hours to 13 days post-infusion
Maximum Concentration (Cmax)
Time Frame: Pre-infusion to 13 days post-infusion
Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Pre-infusion to 13 days post-infusion
Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose
Time Frame: Pre-infusion to 13 days post-infusion
AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Pre-infusion to 13 days post-infusion
Clearance (Cl)
Time Frame: Pre-infusion to 13 days post-infusion
Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Pre-infusion to 13 days post-infusion
Mean Residence Time (MRT)
Time Frame: Pre-infusion to 13 days post-infusion
MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Pre-infusion to 13 days post-infusion
Volume of Distribution at Steady State (Vss)
Time Frame: Pre-infusion to 13 days post-infusion
Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.
Pre-infusion to 13 days post-infusion
Incremental In Vivo Recovery (IVR)
Time Frame: Pre-infusion to 4 hours post-infusion
Maximum fibrinogen activity increase in plasma per mg/kg dosed
Pre-infusion to 4 hours post-infusion
Classical In Vivo Recovery (IVR)
Time Frame: Pre-infusion to 4 hours post-infusion
Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose
Pre-infusion to 4 hours post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BI3023_2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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