Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage) (AmAREtTI)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    60
  • sponsor
    CSL Behring
Updated on 20 August 2022
deficiency
self-administration
alpha1-proteinase inhibitor (human)

Summary

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.

Details
Condition Alpha-1 Antitrypsin Deficiency
Clinical Study IdentifierNCT04262284
SponsorCSL Behring
Last Modified on20 August 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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