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Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors

NCT01505946 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2013-06-17

No results posted yet for this study

Summary

This is an observational, prospective, longitudinal, multicenter, cohort study designed with the scope to verify whether or not TGA may predict effectiveness of different FVIII concentrates class (devoid or rich of VWF) in patient affected by severe or moderately severe inherited haemophilia A and inhibitors.

Conditions

  • Severe Hemophilia A With Inhibitor

Interventions

OTHER

TGA (Thrombin generation Assay)

TGA will be performed on plasma in order to evaluate differences in the ability to stimulate the thrombin generation among the different class of FVIII concentrates and possibly identify the "most effective". The TGA will be quarterly repeated in order to verify if it is also adequate to check the therapy effectiveness during the study period

Sponsors & Collaborators

  • Thrombinoscope

    collaborator UNKNOWN

  • Grifols Italia S.p.A

    lead INDUSTRY

Principal Investigators

  • Elena Santagostino, MD, PhD · Angelo Bianchi Bonomi" Haemophilia Thrombosis Centre I.R.C.S.S. Maggiore Hospital and University of Milan Via Pace 9, 20122 Milan - Italy

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505946 on ClinicalTrials.gov