Trial · NCT00496262
Human Fibrinogen - Pharmacokinetics
NCT00496262, Phase 2, Completed, CSL Behring; results first posted 2009-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Human Fibrinogen - Pharmacokinetics. Trials, record NCT00496262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496262
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Human Fibrinogen - Pharmacokinetics
- NCT number
- NCT00496262
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Fibrinogen Deficiency
- Interventions
- Human Fibrinogen Concentrate
- First posted
- 2007-07-04
- Last updated
- 2016-09-15
- Results first posted
- 2009-07-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Clot Firmness (MCF) | 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. |
| Secondary | Terminal Elimination Half-life (t1/2) | 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. |
| Secondary | Maximum Concentration (Cmax) | Pre-infusion to 13 days post-infusion | Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. |
| Secondary | Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose | Pre-infusion to 13 days post-infusion | AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. |
| Secondary | Clearance (Cl) | Pre-infusion to 13 days post-infusion | Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. |
| Secondary | Mean Residence Time (MRT) | Pre-infusion to 13 days post-infusion | MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. |
| Secondary | Volume of Distribution at Steady State (Vss) | Pre-infusion to 13 days post-infusion | Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame. |
| Secondary | Incremental In Vivo Recovery (IVR) | Pre-infusion to 4 hours post-infusion | Maximum fibrinogen activity increase in plasma per mg/kg dosed |
| Secondary | Classical In Vivo Recovery (IVR) | Pre-infusion to 4 hours post-infusion | Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Clot Firmness (MCF) | Pre-infusion and 1 hour post-infusion | 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.) | millimeters | MEAN |
| SECONDARY | Terminal Elimination Half-life (t1/2) | 0.5 hours to 13 days post-infusion | 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). | hours | MEAN |
| SECONDARY | Maximum Concentration (Cmax) | Pre-infusion to 13 days post-infusion | 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). | g/L | MEAN |
| SECONDARY | Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose | Pre-infusion to 13 days post-infusion | 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). | hour*mg/mL | MEAN |
| SECONDARY | Clearance (Cl) | Pre-infusion to 13 days post-infusion | 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). | mL/hour/kg | MEAN |
| SECONDARY | Mean Residence Time (MRT) | Pre-infusion to 13 days post-infusion | 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). | hours | MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) | Pre-infusion to 13 days post-infusion | 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). | mL/kg | MEAN |
| SECONDARY | Incremental In Vivo Recovery (IVR) | Pre-infusion to 4 hours post-infusion | 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). | mg/dL increase per mg/kg body weight | MEDIAN |
| SECONDARY | Classical In Vivo Recovery (IVR) | Pre-infusion to 4 hours post-infusion | 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). | % of expected increase in fibrinogen | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Clot Firmness (MCF) | Pre-infusion | 0 | Standard Deviation 0 | millimeters | |
| Maximum Clot Firmness (MCF) | 1 Hour Post-infusion | 8.9 | Standard Deviation 4.4 | millimeters | |
| Terminal Elimination Half-life (t1/2) | Human Fibrinogen Concentrate | 78.7 | Standard Deviation 18.1 | hours | |
| Maximum Concentration (Cmax) | Human Fibrinogen Concentrate | 1.4 | Standard Deviation 0.27 | g/L | |
| Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose | Human Fibrinogen Concentrate | 124.3 | Standard Deviation 24.16 | hour*mg/mL | |
| Clearance (Cl) | Human Fibrinogen Concentrate | 0.59 | Standard Deviation 0.13 | mL/hour/kg | |
| Mean Residence Time (MRT) | Human Fibrinogen Concentrate | 92.8 | Standard Deviation 20.1 | hours | |
| Volume of Distribution at Steady State (Vss) | Human Fibrinogen Concentrate | 52.7 | Standard Deviation 7.48 | mL/kg | |
| Incremental In Vivo Recovery (IVR) | Human Fibrinogen Concentrate | 1.7 | Full Range 1.3 to 2.7 | mg/dL increase per mg/kg body weight | |
| Classical In Vivo Recovery (IVR) | Human Fibrinogen Concentrate | 61.8 | Full Range 52.5 to 97.4 | % of expected increase in fibrinogen |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Human Fibrinogen Concentrate | 15 | |
| Overall Study | COMPLETED | Human Fibrinogen Concentrate | 15 | |
| Overall Study | NOT COMPLETED | Human Fibrinogen Concentrate | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Human Fibrinogen Concentrate | 1 | 15 | 1 |
| other | Pain | General disorders | Human Fibrinogen Concentrate | 1 | 15 | 1 |
| other | Headache | Nervous system disorders | Human Fibrinogen Concentrate | 1 | 15 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Human Fibrinogen Concentrate | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Human Fibrinogen Concentrate | ||
| Total, other adverse events | Human Fibrinogen Concentrate | 2 | 15 |
| Total, serious adverse events | Human Fibrinogen Concentrate | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19804533 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00496262
GET https://conductscience.org/api/trials/v1/NCT00496262/registered