Trial · NCT02281500
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Fibrinogen Concentration-time Curve (AUC) From Time Zero to 14 Days (AUC0-14days) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hour*grams per liter (h*g/L) | MEAN |
| PRIMARY | Area Under the Plasma Fibrinogen Concentration-time Curve (AUC) From Time Zero to 14 Days (AUC0-14days) of FIB Grifols Determined by Enzyme-Linked Immunosorbent Assay (ELISA) Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hour*milligram per milliliter (h*mg/mL) | MEAN |
| PRIMARY | AUC From Time Zero to Infinite Time (AUC0-infinity) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hours*gram per liter (h*g/L) | MEAN |
| PRIMARY | AUC From Time Zero to Infinite Time (AUC0-infinity) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | h*mg/mL | MEAN |
| PRIMARY | Maximum Observed Peak Plasma Fibrinogen Concentration (Cmax) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | gram per liter (g/L) | MEAN |
| PRIMARY | Maximum Observed Peak Plasma Fibrinogen Concentration (Cmax) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | milligram per milliliter (mg/mL) | MEAN |
| PRIMARY | Time to Reach Maximum Plasma Fibrinogen Concentration (Tmax) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here, the 'number of participants analyzed' signifies participants who were evaluable for this outcome measure. | hour (h) | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Fibrinogen Concentration (Tmax) of FIB Grifols Determined by ELISA Method | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here, the 'number of participants analyzed' signifies participants who were evaluable for this outcome measure. | hour (h) | MEDIAN |
| PRIMARY | Apparent Terminal Half-life (t1/2) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hour (h) | MEAN |
| PRIMARY | Apparent Terminal Half-life (t1/2) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hour (h) | MEAN |
| PRIMARY | Mean Residence Time (MRT) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hour (h) | MEAN |
| PRIMARY | Mean Residence Time (MRT) of FIB Grifols Assessed Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | hour (h) | MEAN |
| PRIMARY | Volume of Distribution (Vd) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | milliliter per kilogram (mL/kg) | MEAN |
| PRIMARY | Volume of Distribution (Vd) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | mL/kg | MEAN |
| PRIMARY | Clearance (Cl) of FIB Grifols Determined By Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | mL per hour per kilogram (mL/h/kg) | MEAN |
| PRIMARY | Clearance (Cl) of FIB Grifols Determined By ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | mL/h/kg | MEAN |
| PRIMARY | In Vivo Recovery (IVR) of FIB Grifols Determined by Clauss Method | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | milligram per deciliter (mg/dL)/ (mg/kg) | MEAN |
| PRIMARY | In Vivo Recovery (IVR) of FIB Grifols Determined by ELISA Method | Pre-infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 336 hours post-infusion | The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | (mg/dL)/(mg/kg) | MEAN |
| PRIMARY | Mean Change on Maximum Clot Firmness (MCF) From Baseline to 1-hour Post-infusion | Baseline to 1-hour post-infusion | The Evaluable population included all participants who received Investigational Product (IP) at any amount and who had at least two measurements, pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | millimeter (mm) | MEAN |
| SECONDARY | Mean Change in Clotting Time (CT) From Baseline to 1-hour Post-infusion | Baseline to 1-hour post-infusion | The Evaluable population included participants who received investigational product at any amount and who had at least 2 measurements pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Seconds (sec) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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