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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Fibrinogen Concentrate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Fibrinogen Concentrate | Biological | Single intravenous infusion of 70 mg/kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-infusion and 1 hour post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal Elimination Half-life (t1/2) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program Director, Clinical R&D | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact CSL Behring for facility details | Aurora | Colorado | 80045 | United States | ||
| Contact CSL Behring for facility details |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19804533 | Result | 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. |
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Subjects were enrolled at study sites in the USA and Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Fibrinogen Concentrate | All enrolled subjects received a single IV infusion of 70 mg/kg body weight of human fibrinogen concentrate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Human Fibrinogen Concentrate | Includes all subjects who received any portion of the infusion of human fibrinogen concentrate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects in the intention to treat (ITT) population. The ITT population included all subjects who received any portion of any infusion of human fibrinogen concentrate. (Note: 2 subjects in the ITT population had missing MCF data; the change from baseline MCF was entered as 0.0 for these subjects.) | Posted | Mean | Standard Deviation | millimeters | Pre-infusion and 1 hour post-infusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Human Fibrinogen Concentrate | Includes all subjects who received any portion of the infusion of human fibrinogen concentrate. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Director, Clinical R&D | CSL Behring | Use email contact. | clinicaltrials@cslbehring.com |
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| ID | Term |
|---|---|
| D000347 | Afibrinogenemia |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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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 | 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) | 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) | 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) | 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) | Maximum fibrinogen activity increase in plasma per mg/kg dosed | Pre-infusion to 4 hours post-infusion |
| Classical In Vivo Recovery (IVR) | Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose | Pre-infusion to 4 hours post-infusion |
| 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 |
| Contact CSL Behring for facility details | Cagliari | 09100 | Italy |
| Contact CSL Behring for facility details | Florence | 50134 | Italy |
| Contact CSL Behring for facility details | Milan | 20122 | Italy |
| Contact CSL Behring for facility details | Naples | 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 |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 1 Hour Post-infusion |
1 hour after end of infusion |
|
|
|
| Secondary | Terminal Elimination Half-life (t1/2) | t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Mean | Standard Deviation | hours | 0.5 hours to 13 days post-infusion |
|
|
|
| Secondary | Maximum Concentration (Cmax) | Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Mean | Standard Deviation | g/L | Pre-infusion to 13 days post-infusion |
|
|
|
| Secondary | 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. | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Mean | Standard Deviation | hour*mg/mL | Pre-infusion to 13 days post-infusion |
|
|
|
| Secondary | Clearance (Cl) | Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Mean | Standard Deviation | mL/hour/kg | Pre-infusion to 13 days post-infusion |
|
|
|
| Secondary | Mean Residence Time (MRT) | MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Mean | Standard Deviation | hours | Pre-infusion to 13 days post-infusion |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) | Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame. | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Mean | Standard Deviation | mL/kg | Pre-infusion to 13 days post-infusion |
|
|
|
| Secondary | Incremental In Vivo Recovery (IVR) | Maximum fibrinogen activity increase in plasma per mg/kg dosed | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Median | Full Range | mg/dL increase per mg/kg body weight | Pre-infusion to 4 hours post-infusion |
|
|
|
| Secondary | Classical In Vivo Recovery (IVR) | Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose | The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14). | Posted | Median | Full Range | % of expected increase in fibrinogen | Pre-infusion to 4 hours post-infusion |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| Pain | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
The investigator must provide a copy of any results communication to the sponsor for review at least 30 days prior to public release. The sponsor may request any changes necessary to prevent forfeiture of patent rights to data not in the public domain. For a multi-center study, the investigator must wait (i) at least 1 year after the study is completed at all sites or (ii) until notified by the sponsor that no multi-center publication is planned before seeking publication review.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |