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Alpha-1 Antitrypsin Deficiency

Respreeza® Self-administration and Learning Program (AmAREtTI Study)
NCT04262284 | Observational

According to the Respreeza® Summary of Product Characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although subsequent infusions may be administered at home by the person responsible for care or by the patient. Clinical data on self-administration of Respreeza® are however limited and the grounds for self-administration are left to the assessment of the attending physician, who needs to ensure that appropriate training is delivered. In this context, CSL Behring would like to run a clinical study in order to assess the effectiveness of a home self-administration learning program in terms of switching to self-administration, and the long term maintenance of this administration.

Trial Information
10 Sites
60 Participants
18 Years

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CHU Angers
CHU Bordeaux Hpital HautLvque
CHU GrenobleAlpes
CHU Lille
Hospices Civils de Lyon
Hpital Saint Joseph
Hpital BichatClaudeBernard
CHU Rennes Hpital Pontchaillou
CHU Strasbourg
CHRU Tours

Study Eligibility Criteria

  • Adult patients (age ≥18 years old).
  • Patients suffering from AATD treated by Respreeza® through a peripheral vein at home for at least 3 month (consecutives or not). The 3-month period of treatment with Respreeza® does not necessarily correspond to the 3 months prior to inclusion.
  • Patient accompanied by a third person at home
  • Patients deemed to be suitable by the investigator for self-administration.
  • Patients with a life expectancy of over 3 years.
  • Patients who have been informed verbally and in writing via the information leaflet and who have signed the informed consent form.
  • - In order to reflect the reality of everyday practice, no non-inclusion criteria are intended except for patient refusal to take part in the study.

Additional Studies

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