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

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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

December 2022

Primary Completion Date

December 2022

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

          -  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

February 2020