Thrombin Generation Numerical Models Validation in Haemophilic Case

NCT02300519

Last updated date
Study Location
Chu Saint-Etienne
Saint-Etienne, , 42055, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Haemophilia B, Haemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Signed consent form

- Age between 18 and 45 years old

- Male

- no smoker

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- other clinical research protocol participation during the 3 months before inclusion


- Personal or familial history of hemorrhagic disease (parents, brothers and sisters


- Personal history of thrombosis (arterial or venous)


- Familial history of thrombosis before 45 years old (parents, brothers and sisters)


- Drug treatments of aspirin or anti-inflammatory type during the week before sampling


- Surgery the month before sampling


- Chronic pathology responsible for inflammatory syndrome


- Infectious episode in course

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Haemophilia B, Haemophilia AThrombin Generation Numerical Models Validation in Haemophilic Case
NCT02300519
  1. Saint-Etienne,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Thrombin Generation Numerical Models Validation in Haemophilic Case
Official Title Thrombin Generation Numerical Models Validation in Haemophilic Case
Brief Summary Personalized therapy in haemophilia has not been reached yet. Treatment is substitutive and its doses are only based on the levels of deficient factor VIII (for haemophilia A) or IX (for haemophilia B). The bleeding severity is not only related to the factor deficiency but also to levels of other coagulation factors (e.g. factor X, II, AT or TFPI). It's necessary to take them into account in order to individualize treatments; and Thrombin Generation Assay (TGA) with the CAT method (Calibrated Automated Thrombography) is a good way because it measures the result of the coagulation cascade. TGA on Platelet Rich Plasma (PRP) is even closer to physiological conditions than on Platelet Poor Plasma (PPP) because platelet influence is represented. It has already been shown (at least in PPP) that the bleeding tendency in haemophilic patients is usually well correlated to TG. Some TG parameters are used to characterize the individual coagulation phenotype, the most important being the Endogenous Thrombin Potential (ETP) and the Lag Time (LT). A hemorrhagic profile usually provides a longer lag time and / or a lower ETP. However, only few studies tried to determine the influence of each coagulation factor and inhibitor on TG. They were done on Platelet Poor Plasma (PPP) or on lyophilized plasma. So the relation between coagulation factors and the different TG parameters remains to be determined, especially in the haemophilic case. It is possible, experimentally, to find the optimal dose of the factor to be added by measuring TG in samples with different factor VIII or IX concentrations, but this method would be time consuming and expensive, especially because it should be done for each haemophilic patient. A better way consists in using TG numerical models. For a set of initial factor levels they simulate the TG and its associated parameters. It is now essential to validate the existing models, especially in haemophilic cases, in order to see whether they are reliable and can be used in clinical practice afterwards.The objective of this study is to validate thrombin generation numerical models which could predict the factor VIII or IX activity correction to reach a thrombin generation sufficient to avoid bleeding. A comparison between the TG observed in haemophilic patients and the TG predicted by the models is needed to validate the models. In order to define a 'safe' TG i.e. sufficient to avoid bleeding, normal ranges of TG parameters have to be measured.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood
Sampling Method Non-Probability Sample
Study Population volunteers witch work in CHU Saint-Etienne
Condition
  • Haemophilia B
  • Haemophilia A
Intervention Other: blood sampling
Samplings will be taken on 4 citrated S-monovette tubes, 3 citrated tubes and 1 EDTA tube, namely 36.5 ml for each volunteer
Study Groups/Cohorts Volunteers
Blood sampling : 1 blood punction of 36.5 ml for each volunteer
Intervention: Other: blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 21, 2014)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Signed consent form
  • Age between 18 and 45 years old
  • Male
  • no smoker

Exclusion Criteria:

  • other clinical research protocol participation during the 3 months before inclusion
  • Personal or familial history of hemorrhagic disease (parents, brothers and sisters
  • Personal history of thrombosis (arterial or venous)
  • Familial history of thrombosis before 45 years old (parents, brothers and sisters)
  • Drug treatments of aspirin or anti-inflammatory type during the week before sampling
  • Surgery the month before sampling
  • Chronic pathology responsible for inflammatory syndrome
  • Infectious episode in course
Sex/Gender
Sexes Eligible for Study:Male
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02300519
Other Study ID Numbers 1408185
2014-A01734-43 ( Other Identifier: ANSM - FRANCE )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators
  • Pfizer
  • Ecole Normale Supérieure des Mines de Saint-Etienne
Investigators
Principal Investigator:Brigitte TARDY-PONCET, MDCHU SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date August 2015