Brief Title
Respreeza® Self-administration and Learning Program (AmAREtTI Study)
Official Title
Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage)
Brief 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.
Study Type
Observational
Primary Outcome
Percentage of patients who switch to self-administration without the presence of a nurse at the end of the learning program
Secondary Outcome
Percentage of patients who switch to self-administration without the presence of a nurse
Condition
Alpha-1 Antitrypsin Deficiency
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
60
Start Date
October 18, 2019
Completion Date
March 31, 2023
Primary Completion Date
March 31, 2023
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Study Physician, 610-878-4000, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04262284
Organization ID
AmAREtTI
Secondary IDs
2018-A02601-54
Responsible Party
Sponsor
Study Sponsor
CSL Behring
Study Sponsor
Study Physician, Study Director, CSL Behring SA
Verification Date
October 2021