Clinical Trials Logo
  1. Home
  2. Pharmacokinetics
  3. NCT05503498
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00746499 - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women. Phase 1
Completed NCT01055964 - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients Phase 3
Completed NCT01276119 - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00856570 - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects Phase 1