search
Back to results

Human Fibrinogen - Pharmacokinetics

Primary Purpose

Fibrinogen Deficiency

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Human Fibrinogen Concentrate
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrinogen Deficiency focused on measuring Congenital fibrinogen deficiency, Fibrinogen concentrate, Pharmacokinetics, Thrombelastography

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human Fibrinogen Concentrate

Arm Description

Outcomes

Primary Outcome Measures

Maximum Clot Firmness (MCF)
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2007
Last Updated
July 27, 2016
Sponsor
CSL Behring
search

1. Study Identification

Unique Protocol Identification Number
NCT00496262
Brief Title
Human Fibrinogen - Pharmacokinetics
Official Title
Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrinogen Deficiency
Keywords
Congenital fibrinogen deficiency, Fibrinogen concentrate, Pharmacokinetics, Thrombelastography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human Fibrinogen Concentrate
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Human Fibrinogen Concentrate
Other Intervention Name(s)
Haemocomplettan® P, RiaSTAP
Intervention Description
Single intravenous infusion of 70 mg/kg body weight
Primary Outcome Measure Information:
Title
Maximum Clot Firmness (MCF)
Description
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.
Time Frame
Pre-infusion and 1 hour post-infusion
Secondary Outcome Measure Information:
Title
Terminal Elimination Half-life (t1/2)
Description
t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Time Frame
0.5 hours to 13 days post-infusion
Title
Maximum Concentration (Cmax)
Description
Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Time Frame
Pre-infusion to 13 days post-infusion
Title
Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose
Description
AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Time Frame
Pre-infusion to 13 days post-infusion
Title
Clearance (Cl)
Description
Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Time Frame
Pre-infusion to 13 days post-infusion
Title
Mean Residence Time (MRT)
Description
MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Time Frame
Pre-infusion to 13 days post-infusion
Title
Volume of Distribution at Steady State (Vss)
Description
Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.
Time Frame
Pre-infusion to 13 days post-infusion
Title
Incremental In Vivo Recovery (IVR)
Description
Maximum fibrinogen activity increase in plasma per mg/kg dosed
Time Frame
Pre-infusion to 4 hours post-infusion
Title
Classical In Vivo Recovery (IVR)
Description
Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose
Time Frame
Pre-infusion to 4 hours post-infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Program Director, Clinical R&D
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Contact CSL Behring for facility details
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Contact CSL Behring for facility details
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Contact CSL Behring for facility details
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Napoli
ZIP/Postal Code
80122
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Palermo
ZIP/Postal Code
90134
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Contact CSL Behring for facility details
City
Vicenza
ZIP/Postal Code
36100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19804533
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.
Results Reference
result
Links:
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00496262&registryName=ctgov
Description
Click here to request more information about this study

Learn more about this trial

Human Fibrinogen - Pharmacokinetics

We'll reach out to this number within 24 hrs