Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
1
AUTOIMMUNE XEROSTOMIA
Key facts
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07]
- Trial duration
- 13 Sep 2024 → ongoing
- Decision date (initial)
- 2023-11-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505149-20-00
- ClinicalTrials.gov
- NCT05857358
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
AUTOIMMUNE XEROSTOMIA
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Marseille
- Sponsor organisation
- Assistance Publique Hopitaux De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Marseille
- Contact name
- PROJECT MANAGER
Public contact point
- Organisation
- Assistance Publique Hopitaux De Marseille
- Contact name
- PROJECT MANAGER
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-09-13 | 2024-09-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2026-02-19
- Type
- 4
- Reason
- 7
- Immediate action required
- No
- Justification
- As part of its activities, the APHM sent an email 26/11/2025 to the ANSM to inform it of an unexpected change in the design of a critical medical device (MD): the diameter of one of the tubes in the PUREGRAFT bag, used for the initial collection of adipose tissue and for the first stages of manufacture. This modification, which could impact the quality of the sterile connection, required an immediate adaptation of the process.
This change affects six clinical trials:2024-516342-19-00 2024-513306-65-00,2024-517384-24-
00,2023-505149-20-00 2024-517794-24-00 et 2024-511858-44-00
In order to guarantee the quality and sterility of the product, a new transfer set has been introduced. This set, custom-made by Sartorius, is subjected to gamma irradiation to meet sterility requirements. From a quality management perspective, this change has been formally managed, incorporating all prior validations: documentary, aseptic, MPT, surgical use, leak testing, as well as the associated validation batches.
The IMPD will be gradually updated during 2026 to ensure the traceability and regulatory compliance of this change.
The sponsor is requested to submit immediately an MSA part I + II inclunding
- The applicant must provide a photo/diagram or detailed description of the new device (transfer set) and the contact time with the product.
- Proof of CE marking or the device's certificate of conformity must be provided.
- The documents available as mentioned in the initial email regarding prior validations of the device (documentary, aseptic, MPT, surgical use, watertightness, validation batches) must be provided.
- The complete change control report must be provided.
so that the ANSM can evaluate the change in sterile connection and allow it to continue to be included in this clinical trial
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-19 | France | Acceptable 2023-10-20
|
2023-11-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-22 | France | Acceptable 2025-12-19
|
2025-12-19 |