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Use of a TGA and TEM in the Assessment of the Efficacy of Treatment With APCC or rFVIIa Concentrate in Patients With Acquired Haemophilia and in Patients With Haemophilia A With Inhibitors


N/A
18 Years
N/A
Not Enrolling
Both
Haemophilia

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Trial Information

Use of a TGA and TEM in the Assessment of the Efficacy of Treatment With APCC or rFVIIa Concentrate in Patients With Acquired Haemophilia and in Patients With Haemophilia A With Inhibitors


This section is Not applicable


Inclusion Criteria:



- patients with acquired haemophilia

- patients with congenital haemophilia A with inhibitor

Exclusion Criteria:

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Assessment of patient's individual response to therapy with by-passing agents by simultaneous use of TGA and TEM methods.

Outcome Description:

This is non-inverventional study as the protocol will not assign specific treatment to the particular subjects of the study. Patients will be treated with APCC or rFVIIa based on the experience of the study site. Patients are prescribed a treatment according to their physician's judgement or local clinical practice. This is observation of the everyday clinical practise on site.

Outcome Time Frame:

48 hours

Safety Issue:

No

Principal Investigator

Maria Podolak-Dawidziak, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Blood Neoplasms and Bone Marrow Transplantation of the Wroclaw Medical University

Authority:

Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

TGA-TEM

NCT ID:

NCT01856751

Start Date:

June 2013

Completion Date:

June 2016

Related Keywords:

  • Haemophilia
  • Haemophilia
  • TGA
  • TEM
  • Hemophilia A

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