Respreeza® Self-administration and Learning Program (AmAREtTI Study) (AmAREtTI)
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 |
Recruitment Status :
Active, not recruiting
First Posted : February 10, 2020
Last Update Posted : April 19, 2024
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Tracking Information | |||||
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First Submitted Date | February 4, 2020 | ||||
First Posted Date | February 10, 2020 | ||||
Last Update Posted Date | April 19, 2024 | ||||
Actual Study Start Date | October 18, 2019 | ||||
Estimated Primary Completion Date | March 31, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Patients suffering from alpha-1 antitrypsin deficiency (AATD) treated by Respreeza® | ||||
Condition | Alpha-1 Antitrypsin Deficiency | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
60 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 31, 2025 | ||||
Estimated Primary Completion Date | March 31, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
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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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04262284 | ||||
Other Study ID Numbers | AmAREtTI 2018-A02601-54 ( Other Identifier: ANSM ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | CSL Behring | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | CSL Behring | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | CSL Behring | ||||
Verification Date | April 2024 |