Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach

2 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

July 1, 2007

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 10, 2009

Completed

Last Updated

September 15, 2016

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

July 3, 2007

Results QC Date

May 19, 2009

Last Update Submit

July 27, 2016

Conditions

Fibrinogen Deficiency

Keywords

Congenital fibrinogen deficiencyFibrinogen concentratePharmacokineticsThrombelastography

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

Terminal Elimination Half-life (t1/2)
0.5 hours to 13 days post-infusion
Maximum Concentration (Cmax)
Pre-infusion to 13 days post-infusion
Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose
Pre-infusion to 13 days post-infusion
Clearance (Cl)
Pre-infusion to 13 days post-infusion
Mean Residence Time (MRT)
Pre-infusion to 13 days post-infusion
+3 more secondary outcomes

Study Arms (1)

Human Fibrinogen Concentrate

EXPERIMENTAL

Biological: Human Fibrinogen Concentrate

Interventions

Human Fibrinogen ConcentrateBIOLOGICAL

Single intravenous infusion of 70 mg/kg body weight

Also known as: Haemocomplettan® P, RiaSTAP

Human Fibrinogen Concentrate

Eligibility Criteria

Age6 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.