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NCT05503498 Clinical Trial

Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

PHARMACOKINETICS Clinical Trial

— PKMF  

Official title:
Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05503498
Other study ID # PMODEL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date August 1, 2022

Study information
Verified date August 2022
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

Description:

Fibrinogen, a plasma-soluble protein synthesized by the liver, is the key substrate for the plasmatic blood coagulation, reaching a critically low plasma concentration earlier than other coagulation factors in case of bleeding. Fibrinogen Pharmacokinetics (PK) after single doses of fibrinogen concentrate (FC), using modeling approaches, has only been evaluated in congenital afibrinogenaemic patients. The aims of this study are to extend the modeling process to characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production. Influencing factors of differences on the fibrinogen PK between sub-populations will be identified.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION - Exclusion Criteria: NA -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• DATA RECORDING
RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION

Locations
Country Name City State
Spain Hospital Clinic Barcelona
Spain Hospitla Clinic Barcelona

Sponsors (2)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary plasma fibrinogen level to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration JUNE 2021- AUGUST 2022
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