Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
104
Countries
1
Sites
3
transthyretin cardiac amyloidosis
Key facts
- Sponsor
- Universita' Degli Studi Di Genova
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
transthyretin cardiac amyloidosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10087643 | Transthyretin cardiac amyloidosis | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universita' Degli Studi Di Genova
- Sponsor organisation
- Universita' Degli Studi Di Genova
- Address
- Viale Benedetto XV N 6
- City
- Genoa
- Postcode
- 16132
- Country
- Italy
Scientific contact point
- Organisation
- Universita' Degli Studi Di Genova
- Contact name
- Marco Canepa
Public contact point
- Organisation
- Universita' Degli Studi Di Genova
- Contact name
- Marco Canepa
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 104 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
IRCSS Ospedale Policlinico San Martino
CardioToraco Vascolare (DICATOV), Largo Rosanna Benzi 10, 16132, Genova
Università Sapienza, Azienda Ospedaliera Sant’Andrea
UOC Cardiologia, Via di Grottarossa 1035, 00189, Roma
Azienda Ospedaliera Universitaria Careggi
Terapia Cardiaca Intensiva, Largo Brambilla 3, 50134, Firenze
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-06 | Italy | Acceptable 2025-03-19
|
2025-05-27 |