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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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