Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients

NCT02540187

Last updated date
Study Location
CHRU Lille
Lille, , , France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Haemophilia A and B patients between 18 and 65 years old, whatever the severity of their disease, who have signed the informed consent form

- On-demand or on prophylactic therapy.

- Regular monitoring in investigator center.

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


- - Haemophilia patients under 18.


- Presence of an inhibitor at any time before or during the study period.


- Patients who received factor VIII concentrate less than 72 hours or factor IX
concentrate less than 96 hours before blood collection


- Patients who refused to sign informed consent


- Patient data over the last 5 years at least not available.


- No regular monitoring in haemophilia center (required at least one visit every 18
months for severe or moderate hemophiliac patients).

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HemophiliaTissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients
NCT02540187
  1. Lille,
  2. Lyon,
  3. Marseille,
  4. Nancy,
  5. Reims,
  6. Saint-Etienne,
  7. Tours,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients
Official Title Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients
Brief Summary

Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX) deficiency. According to the intensity of the defect, there are three forms of haemophilia: severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic manifestations are variable from one patient to the other. Moreover, several studies showed that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that haemophilic A patients.

The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the amplification pathway being strongly altered because of factor VIII or IX deficiency, thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.

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 specimen
Sampling Method Probability Sample
Study Population Haemophilia A and B patients between 18 and 65 years old, whatever the severity of their disease
Condition Hemophilia
Intervention Other: blood specimen
Study Groups/Cohorts
  • haemophilia A
    1. Blood specimen for measuring :

      • Free TFPI and TFPI activity levels
      • Thrombin generation in platelet rich plasma (PRP) and platelet poor plasma (PPP)
      • Thrombin generation assay (TGA) in fresh PRP and frozen PPP
    2. Hemorrhage score for each patient
    Intervention: Other: blood specimen
  • Haemophilia B
    1. Blood specimen for measuring :

      • Free TFPI and TFPI activity levels
      • Thrombin generation in platelet rich plasma (PRP) and platelet poor plasma (PPP)
      • Thrombin generation assay (TGA) in fresh PRP and frozen PPP
    2. Hemorrhage score for each patient
    Intervention: Other: blood specimen
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: September 1, 2015)
164
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Haemophilia A and B patients between 18 and 65 years old, whatever the severity of their disease, who have signed the informed consent form
  • On-demand or on prophylactic therapy.
  • Regular monitoring in investigator center.

Exclusion Criteria:

  • - Haemophilia patients under 18.
  • Presence of an inhibitor at any time before or during the study period.
  • Patients who received factor VIII concentrate less than 72 hours or factor IX concentrate less than 96 hours before blood collection
  • Patients who refused to sign informed consent
  • Patient data over the last 5 years at least not available.
  • No regular monitoring in haemophilia center (required at least one visit every 18 months for severe or moderate hemophiliac patients).
Sex/Gender
Sexes Eligible for Study:Male
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02540187
Other Study ID Numbers 1108164
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
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date March 2016