Respreeza® Self-administration and Learning Program (AmAREtTI Study) (AmAREtTI)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04262284 |
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Recruitment Status :
Active, not recruiting
First Posted : February 10, 2020
Last Update Posted : April 19, 2024
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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 |
| 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, 2025 |
| Estimated Study Completion Date : | March 31, 2025 |
- 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
- Percentage of patients who switch to self-administration without the presence of a nurse [ Time Frame: Up to 12 months ]
- 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
- 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)
- 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
- 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.
- Evolution of patients Quality of Life with Saint George's Respiratory Questionnaire (SGRQ) [ Time Frame: Up to 12 months ]
- 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
- 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
- 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).
- Compliance/Observance [ Time Frame: Up to 8 weeks ]Compliance/observance measured by the number of scheduled and unrealized sessions.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
| France | |
| CHU Angers | |
| Angers, France | |
| CHU Bordeaux - Hôpital Haut-Lévèque | |
| Bordeaux, France | |
| CHU Grenoble-Alpes | |
| Grenoble, France | |
| CHU Lille | |
| Lille, France | |
| Hospices Civils de Lyon | |
| Lyon, France | |
| Hôpital Saint Joseph | |
| Marseille, France | |
| Hôpital Bichat-Claude-Bernard | |
| Paris, France | |
| CHU Rennes - Hôpital Pontchaillou | |
| Rennes, France | |
| CHU Strasbourg | |
| Strasbourg, France | |
| CHRU Tours | |
| Tours, France | |
| CHU Nancy Brabois | |
| Vandœuvre-lès-Nancy, France | |
| Study Director: | Study Physician | CSL Behring SA |
| 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: | April 19, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |