Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02300519
Other study ID # 1408185
Secondary ID 2014-A01734-43
Status Completed
Phase N/A
First received November 18, 2014
Last updated August 12, 2015
Start date March 2015
Est. completion date July 2015

Study information

Verified date August 2015
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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

Locations

Country Name City State
France Chu Saint-Etienne Saint-Etienne

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Ecole Normale Supérieure des Mines de Saint-Etienne, Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endogenous Thrombin Potential (ETP) predicted by numerical models ETP (i.e. the aera under the thrombin generation curve, nM.min) measured in haemophilic patients is compared to ETP predicted by numerical models. up to 12 monthes No
Primary Lag Time of the thrombin generation curve predicted by numerical models Lag time (min) measured in haemophilic patients is compared to the lag time predicted by numerical models up to 12 monthes No
Primary Peak value of the thrombin generation curve predicted by numerical models Peak value (nmol thrombin) measured in haemophilic patients is compared to the peak value predicted by numerical models up to 12 monthes No
Primary Time to peak (TTP) of the thrombin generation curve predicted by numerical models TTP (min) measured in haemophilic patients is compared to TTP predicted by numerical models up to 12 monthes No
Primary Velocity Index (V) of the thrombin generation curve predicted by numerical models Velocity Index measured in haemophilic patients is compared to TTP predicted by numerical models up to 12 monthes No
Secondary Endogenous Thrombin Potential (ETP) for volunteers ETP (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) day 1 No
Secondary Lag Time of the thrombin generation curve for volunteers Lag time (min) of the thrombin generation curve is measured by Thromboplastin Generation Tests (TGTs) day 1 No
Secondary Peak value of the thrombin generation curve for volunteers Peak value of the thrombin generation curve is measured by Thromboplastin Generation Tests (TGTs) day 1 No
Secondary Time to peak (TTP) of the thrombin generation curve for volunteers TTP of the thrombin generation curve is measured by Thromboplastin Generation Tests (TGTs) day 1 No
Secondary Velocity Index (V) of the thrombin generation curve for volunteers Velocity Index (V) of the thrombin generation curves measured by Thromboplastin Generation Tests (TGTs) day 1 No
See also
  Status Clinical Trial Phase
Completed NCT05082116 - Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10) Phase 3
Completed NCT03660774 - A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
Active, not recruiting NCT04675541 - Register of Patients With haEmophilia A tReated With Afstyla®
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT02246868 - An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients. Phase 3
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT03276130 - Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Enrolling by invitation NCT04574076 - A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01436825 - Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT00245297 - Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes. Phase 2
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Recruiting NCT05621746 - An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct