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

CSL Behring

Status: Completed

Conditions: Alpha-1 Antitrypsin Deficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT04262284

2018-A02601-54 (Other Identifier)

AmAREtTI

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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.