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Trial record 1 of 1 for:    NCT04262284
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Respreeza® Self-administration and Learning Program (AmAREtTI Study) (AmAREtTI)

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ClinicalTrials.gov Identifier: NCT04262284
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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.


Condition or disease
Alpha-1 Antitrypsin Deficiency

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage)
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023





Primary Outcome Measures :
  1. Percentage of patients who switch to self-administration without the presence of a nurse at the end of the learning program [ Time Frame: Up to 8 weeks ]

    A patient will be permitted to switch to self-administration without the presence of a nurse if the following conditions are met:

    • Three consecutive successful self-administrations by the patient in the presence of the nurse but without assistance during the learning phase.
    • Validation of the learning grid The percentage is based on number of patient switching to self-administration and remains in self-administration 12 months after

  2. Percentage of patients who switch to self-administration without the presence of a nurse [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Percentage of patients who switch to self-administration without the presence of a nurse [ Time Frame: Up to 8 weeks ]

    A patient will be permitted to switch to self-administration without the presence of a nurse if the following conditions are met:

    • Three consecutive successful self-administrations by the patient in the presence of the nurse but without assistance during the learning phase.
    • Validation of the learning grid The percentage is based on number of patient switching to self-administration

  2. Patient characteristics [ Time Frame: At inclusion ]
    Socio-demographic data, disease history, concomitant treatments, substitution protocol, percentage of theoretical forced expiratory volume at one second (FEV1), diffusing capacity of lung for carbon monoxide (DLCO), distance from home to hospital, type of follow-up (in hospital, in surgery)

  3. Degree of autonomy [ Time Frame: At inclusion and 12 months after self-administration ]
    The change in the degree of autonomy will be defined as the difference between the autonomy assessed at 12 months and inclusion according to an EVA

  4. The time frame for autonomy [ Time Frame: Up to 12 months ]
    The time to achieve autonomy will be defined by the time between the first learning session for self-administration and the first self-administration without nurse.

  5. Evolution of patients Quality of Life with Saint George's Respiratory Questionnaire (SGRQ) [ Time Frame: Up to 12 months ]
  6. Patients satisfaction for treatment administration by a nurse and for self-administration [ Time Frame: Up to 12 months ]
    Satisfaction for treatment administration by a nurse will be assessed at inclusion by visual analog scale (VAS) Satisfaction for self-administration will be assessed after 12 months after the 1st self-administration or in case of study withdrawal by VAS

  7. Satisfaction about learning program [ Time Frame: Up to 8 weeks ]
    Satisfaction about learning program will be assessed at the end of the learning program by VAS

  8. Tolerance and safety [ Time Frame: Up to 12 months ]
    General and local tolerance at the administration site assessed by the nature and number of adverse events (AEs) and immunoglobulin E impaired gas exchange (IGEs).

  9. Compliance/Observance [ Time Frame: Up to 8 weeks ]
    Compliance/observance measured by the number of scheduled and unrealized sessions.

  10. Determining factors for switch to self-administration [ Time Frame: Up to 8 weeks ]
    Determining factors that may be associated with the transition to self-administration (demographics, disease history, concomitant treatments, substitution protocol, FEV1, QoL at inclusion, duration of learning program).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from alpha-1 antitrypsin deficiency (AATD) treated by Respreeza®
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262284


Contacts
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Contact: Clinical Trials Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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France
CHU Angers Recruiting
Angers, France
CHU Grenoble-Alpes Recruiting
Grenoble, France
CHRU Lille Not yet recruiting
Lille, France
Hospices Civils de Lyon Recruiting
Lyon, France
Hôpital Saint Joseph Not yet recruiting
Marseille, France
Hôpital Bichat-Claude-Bernard Recruiting
Paris, France
CHU Rennes - Hôpital Pontchaillou Recruiting
Rennes, France
CHU Strasbourg Recruiting
Strasbourg, France
CHRU Tours Recruiting
Tours, France
CHU Nancy Brabois Not yet recruiting
Vandœuvre-lès-Nancy, France
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Physician CSL Behring SA
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04262284    
Other Study ID Numbers: AmAREtTI
2018-A02601-54 ( Other Identifier: ANSM )
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes