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Trial record 31 of 36 for:    AMINOCAPROIC ACID

Evaluation of Clot Stability Induced by Solulin: Evaluation of New Solulin Mutants Lacking Protein C Activation Capacity (SOLUCLOT)

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ClinicalTrials.gov Identifier: NCT02911233
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

Hemophilia A is a rare X chromosome-linked recessive bleeding disorder that concerns one individual in 5000. In its severe form, hemophilia A is a life-threatening, crippling hemorrhagic disease. The treatment of bleeding episodes in hemophilia A patients involves the administration of exogenous human FVIII to restore normal hemostasis. The main complication of the substitutive treatment of hemophilia A is the development, in 15 to 30% of the cases, of anti-FVIII antibodies (FVIII inhibitors) that neutralize the pro-coagulant activity of therapeutically administered FVIII. In 2003, the average annual cost of care for a patient with hemophilia A was evaluated to be equal to 63,000 euros (2), which, in France (6000 patients), represents an annual budget of 378 million euros.

In order to reduce the cost of treatment and to bypass this complication, different therapeutic strategies (new products or adjunctive therapeutic options) have been explored, including platelet infusion, tranexamic acid, amino caproic acid, molecules that block tissue factor pathway inhibitor, combination of phospholipid -Factor Xa- Factor XIII and antibodies directed to the Tissue Factor Inhibitor Pathway (TFPI). Recently, Soluble thrombomodulin (Solulin) have been developed. This molecule may be used to partially correct the premature lysis defect in Factor VIII deficient plasma through an activated TAFI - dependent mechanism.

With a long half-life (15- to 30-hour) and effective dose range estimated to range from the sub-nanomolar to approximately 40nM, Solulin could potentially be administered on a weekly basis and provide the basis for a factor-sparing regime that would cut costs and make therapy more widely available. However, before proceeding to advanced trials, safety concerns stemming from the anticoagulant properties of Solulin must be addressed. The development of Solulin mutants lacking protein C activation capacity would make this concern redundant. At the same time, such mutant molecules are likely to possess an effective dose range.

Our project is to compare the behavior of recombinant Solulin and mutants of Solulin lacking protein C activation capacity with respect to their ability to stabilize fibrin clots in whole blood of humans with different coagulation factor deficiencies (hemophilia A, hemophilia B and rare blood coagulation deficiencies (factor X, VII, V).


Condition or disease Intervention/treatment
Hemophilia A Biological: Thromboelastograpgy

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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Study Start Date : March 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia




Primary Outcome Measures :
  1. Evaluation of blood clot firmness in ROTEM experiments using mutant Solulin [ Time Frame: 2 hours ]
  2. Evaluation of fibrinolysis in ROTEM experiments using mutant Solulin [ Time Frame: 2 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- Patients with congenital blood disorder hemophilia A and B
Criteria

Inclusion Criteria:

  • Patients with congenital blood disorder (hemophilia A and B),
  • Inform consent

Exclusion Criteria:

  • Patients with acquired blood disorder.
  • Allo-immunisation against blood coagulation factor concentrates (FVIII inhibitor)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911233


Locations
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France
University Hospital
Caen, Calvados, France, 14000
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02911233     History of Changes
Other Study ID Numbers: 13-136
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn