Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
52
Countries
1
Sites
12
unresectable hepatocellular carcinoma
Key facts
- Sponsor
- University Hospital Grenoble
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Feb 2023 → ongoing
- Decision date (initial)
- 2022-11-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
unresectable hepatocellular carcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Grenoble
- Sponsor organisation
- University Hospital Grenoble
- Address
- Boulevard De La Chantourne, Cs 10217 La Tronche, La Tronche Cs 10217 La Tronche La Tronche
- City
- Grenoble Cedex 9
- Postcode
- 38043
- Country
- France
Scientific contact point
- Organisation
- University Hospital Grenoble
- Contact name
- Anna BOROWIK
Public contact point
- Organisation
- University Hospital Grenoble
- Contact name
- Anna BOROWIK
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 52 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
hepatogastroenterologie, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Centre Hospitalier Universitaire D Angers
hepatogastroenterologie, 4 Rue Larrey, 49933, Angers Cedex 9
Centre Hospitalier Universitaire De Nantes
hepatogastroenterologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Toulouse
hepatogastroenterologie, Cedex 9, 2 Rue Viguerie, Toulouse
Pitie Salpetriere Hospital
hepatogastroenterologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Hopital Beaujon
hepatogastroentérologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Reims
hepatogastroenterologie, 45 Rue Cognacq Jay, 51100, Reims
Centre Léon Bérard
hepatogastroentérologie, 28 rue Laennec, cedex 08, Lyon
Centre Hospitalier Universitaire De Caen Normandie
hepatogastroenterologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Bordeaux
hepatogastroenterologie, 1 Rue Jean Burguet, 33000, Bordeaux
Hopital Saint Antoine
hepatogastroenterologie, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Hopital Saint Joseph
hepatogastroentérologie, 26 Boulevard De Louvain, 13008, Marseille
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 | 2023-02-09 | 2023-03-15 | 2025-03-13 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-25 | France | Acceptable 2022-11-14
|
2022-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-22 | France | Acceptable 2023-03-03
|
2023-03-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-24 | France | Acceptable 2024-07-15
|
2024-08-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-21 | France | Acceptable 2024-12-09
|
2024-12-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-18 | France | Acceptable 2025-04-04
|
2025-04-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-04 | France | Acceptable 2025-08-14
|
2025-08-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-10 | France | Acceptable 2026-03-12
|
2026-03-25 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-22 | France | Acceptable 2026-03-12
|
2026-05-22 |