AGMT_AIHA Registry

Autoimmune Hemolytic Anemia (AIHA) with corresponding Biobank

Synopsis

Short title: AGMT_AIHA-Registry

Title: Autoimmune Hemolytic Anemia (AIHA) with corresponding Biobank

Status: open

Start: October 2016

Coordinating Investigator: Univ. Prof. Dr. Ulrich Jäger

NIS Number: NIS005253

Number of patients: 100 (planned)

Sponsor: AGMT gemeinnützige GmbH

Link to online CRF

Design

This registry is a prospective and retrospective, multicentre collection of data on patients with AIHA in Austria. All disease characteristics, medical histories and also treatment sequences are documented in anonymised form. Additionally patients are asked to complete the FACIT-Fatigue questionnaire. For documentation in the registry no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the project must not interfere with treatment routines.

Data is collected from all sites in Austria willing to participate. An estimated 100 patients are expected to be included; this number may be revised over time as interest and demand dictates.

To help maintain patient confidentiality, each patient is assigned a unique patient identifying number upon enrolment; this number accompanies the patient’s medical and other information throughout the lifetime of the project.

Objectives:
  • Epidemiological evaluations
    • Assessment of AIHA subtypes in Austria
    • Assessment of specific characteristics and frequency of AIHA
  • Patient care and treatment in Austria
    • Treatments used, sequence of treatments
    • Efficacy and toxicity
  • Establishment of a central biobank to provide a basis for future AIHA related research (optional)
Biobank:

For scientific purpose the biomaterial will also be transferred to different specialised laboratories in Austria and abroad (e.g. True North Therapeutics Inc. in San Francisco). True North Therapeutics is working on new drugs against AIHA by testing antibody drug response. These results can be correlated with routine examinations performed in the University Department of Internal Medicine of the Vienna General Hospital to assess whether a patient will benefit from a certain therapy or not.

Inclusion/Exclusion criteria

Inclusion criteria (selected):
  • Signed written informed consent
  • Age 18 years or over
  • Clinical and laboratory signs of AIHA

Due to the non-interventional design of the registry there are no specific inclusion or exclusion criteria.

Register