Trial · NCT02281500

Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia

NCT02281500, Phase 1, Phase 2, Completed, Grifols Therapeutics LLC; results first posted 2020-10-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia. Trials, record NCT02281500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02281500

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
NCT number: NCT02281500
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Grifols Therapeutics LLC
Conditions: Congenital Afibrinogenemia
Interventions: Human Plasma-Derived Fibrinogen Concentrate
First posted: 2014-11-03
Last updated: 2022-03-31
Results first posted: 2020-10-29

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	AUC(0-14days) was calculated by a combination of linear and logarithmic trapezoidal methods and expressed in the unit of concentration × time. The linear trapezoidal method used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method used for those arising from decreasing concentrations. Plasma fibrinogen activity determined by the Clauss method in the central laboratory of the study. Pharmacokinetic (PK) parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	AUC(0-14days) was calculated by a combination of linear and logarithmic trapezoidal methods and expressed in the unit of concentration × time. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	AUC0-infinity was calculated as AUC0-t + Ct/Kel, where (AUC0-t) was the area under the concentration versus (vs) time curve from time 0 to the time of last quantifiable concentration (Ct), and Kel was the apparent terminal first-order elimination rate constant, determined by linear regression analysis of the natural log-linear segment of the plasma concentration-time curve, expressed in time\^-1 units (1/h). Plasma fibrinogen activity was determined by the Clauss method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	AUC0-infinity was calculated as AUC0-t + Ct/Kel, where (AUC0-t) was the area under the concentration vs. time curve from time 0 to the time of last quantifiable concentration (Ct), and Kel was the apparent terminal first-order elimination rate constant, determined by linear regression analysis of the natural log-linear segment of the plasma concentration-time curve, expressed in time\^-1 units (1/h). Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	Cmax was obtained directly from the experimental data without interpolation. Plasma fibrinogen activity was determined by the Clauss method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	Cmax was obtained directly from directly from the experimental data without interpolation. Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	Tmax was obtained directly from the experimental data without interpolation, expressed in time units (hour). Plasma fibrinogen activity was determined by the Clauss method in the central laboratory of the study.
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	Tmax was obtained directly from the experimental data without interpolation, expressed in time units (hour). Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study.
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	t1/2 was the time measured for the concentration to decrease by one half. t1/2 calculated by natural log 2 divided by Kel and expressed in time units (hour). PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.
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	t1/2 was the time measured for the concentration to decrease by one half. t1/2 calculated by natural log 2 divided by Kel and expressed in time units (hour). PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

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.	hourgrams per liter (hg/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.	hourmilligram per milliliter (hmg/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.	hoursgram per liter (hg/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

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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	FIB Grifols 70 mg/kg Body Weight	145.67	Standard Deviation 43.441	hourgrams per liter (hg/L)
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	FIB Grifols 70 mg/kg Body Weight	186.63	Standard Deviation 95.734	hourmilligram per milliliter (hmg/mL)
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	FIB Grifols 70 mg/kg Body Weight	166.78	Standard Deviation 54.081	hoursgram per liter (hg/L)
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	FIB Grifols 70 mg/kg Body Weight	242.94	Standard Deviation 117.567	h*mg/mL
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	FIB Grifols 70 mg/kg Body Weight	1.99	Standard Deviation 0.404	gram per liter (g/L)
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	FIB Grifols 70 mg/kg Body Weight	2.88	Standard Deviation 0.859	milligram per milliliter (mg/mL)
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	FIB Grifols 70 mg/kg Body Weight	1.40	Full Range 1.0 to 24.5	hour (h)
Time to Reach Maximum Plasma Fibrinogen Concentration (Tmax) of FIB Grifols Determined by ELISA Method	FIB Grifols 70 mg/kg Body Weight	1.80	Full Range 1.1 to 24.5	hour (h)
Apparent Terminal Half-life (t1/2) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration	FIB Grifols 70 mg/kg Body Weight	76.94	Standard Deviation 20.215	hour (h)
Apparent Terminal Half-life (t1/2) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration	FIB Grifols 70 mg/kg Body Weight	66.92	Standard Deviation 16.789	hour (h)

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	FIB Grifols 70 mg/kg Body Weight	22
Overall Study	COMPLETED	FIB Grifols 70 mg/kg Body Weight	22
Overall Study	NOT COMPLETED	FIB Grifols 70 mg/kg Body Weight	0

Source ClinicalTrials.gov

Adverse events11

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
other	Abdominal pain	Gastrointestinal disorders	FIB Grifols 70 mg/kg Body Weight	1	22
other	Traumatic haematoma	Injury, poisoning and procedural complications	FIB Grifols 70 mg/kg Body Weight	1	22
other	Blood pressure diastolic decreased	Investigations	FIB Grifols 70 mg/kg Body Weight	1	22
other	Blood pressure systolic decreased	Investigations	FIB Grifols 70 mg/kg Body Weight	1	22
other	Body temperature increased	Investigations	FIB Grifols 70 mg/kg Body Weight	1	22
other	Heart rate increased	Investigations	FIB Grifols 70 mg/kg Body Weight	1	22
other	Headache	Nervous system disorders	FIB Grifols 70 mg/kg Body Weight	1	22
other	Paraesthesia	Nervous system disorders	FIB Grifols 70 mg/kg Body Weight	1	22
other	Menorrhagia	Reproductive system and breast disorders	FIB Grifols 70 mg/kg Body Weight	1	22
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	FIB Grifols 70 mg/kg Body Weight	3	22

1 to 10 of 11Source ClinicalTrials.gov

See all 11 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FIB Grifols 70 mg/kg Body Weight	0	22
Total, other adverse events	FIB Grifols 70 mg/kg Body Weight	9	22
Total, serious adverse events	FIB Grifols 70 mg/kg Body Weight	0	22

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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