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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
Recruiting
18 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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CHU Angers
Angers,France
CHU Bordeaux Hpital HautLvque
Bordeaux,France
CHU GrenobleAlpes
Grenoble,France
CHU Lille
Lille,France
Hospices Civils de Lyon
Lyon,France
Hpital Saint Joseph
Marseille,France
Hpital BichatClaudeBernard
Paris,France
CHU Rennes Hpital Pontchaillou
Rennes,France
CHU Strasbourg
Strasbourg,France
CHRU Tours
Tours,France

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

Additional studies can be found at ClinicalTrials.gov