About Pricing FAQs Blog

Loading clinical trials...

Your health journey, clearly organized.

Find Clinical Trials →

Legal

Privacy Policy
Terms of Service

© 2026 Clareo Health. All rights reserved.

Back to clinical trial search

COMPLETEDPhase 2NCT00496262

Human Fibrinogen - Pharmacokinetics

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 measu...

Lead sponsor: CSL Behring•6 U.S. locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Save this trial guide to your notes

Keep your clinical trial research organized — questions to ask, what to expect, and key details.

Sponsors

Lead Sponsor

CSL Behring

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

Related studies

Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department

NCT07097337 · Trauma Induced Coagulopathy, Trauma Coagulopathy, and more

Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

NCT03793426 · Congenital Fibrinogen Deficiency

WITHDRAWNPhase 3

Fibrinogen Concentrate (Human) - Efficacy and Safety Study

NCT00916656 · Afibrinogenemia, Hypofibrinogenemia, and more

COMPLETEDPhase 2

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

NCT01575756 · Congenital Fibrinogen Deficiency, Afibrinogenemia

An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

NCT02427217 · Congenital Fibrinogen Deficiency

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 15, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment15

Start dateJul 2007

Last updatedSep 15, 2016

Condition

Fibrinogen Deficiency

Locations shown

Contact CSL Behring for facility details

Aurora, Colorado

Contact CSL Behring for facility details

St. Petersburg, Florida

Contact CSL Behring for facility details

Chicago, Illinois

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Start free trial →

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions