Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
4
Sites
11
Hepatitis B, Chronic
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- completed 3 Dec 2024
- Decision date (initial)
- 2024-11-15
- 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
Hepatitis B, Chronic
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 6 | 2 |
| France | Ended | 5 | 3 |
| Italy | Ended | 5 | 3 |
| Spain | Ended | 7 | 3 |
| Rest of world
Thailand, United States
|
— | 9 | — |
Investigational sites
Diagnostic-Consultative Center Alexandrovska EOOD
N/A, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Hopital Beaujon
Service d'Hépatologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Les Hopitaux Universitaires De Strasbourg
Nouvel Hopital Civil - Medical unit of Hepato-gastroenterology and endoscopy, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Hospices Civils De Lyon
Hopital de la Croix Rousse - Hepatogastroenterology, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
SC Gastroenterologia 1, Epatologia e Trapiantologia, Piazza Oms 1, 24127, Bergamo
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
SC Gastroenterologia ed Epatologia, Via Francesco Sforza 28, 20122, Milan
Fondazione IRCCS San Gerardo Dei Tintori
Centro Ricerca di Fase I, Via Giovanni Battista Pergolesi 33, 20900, Monza
Hospital Universitario Marques De Valdecilla
Digestive system service, Avenida Valdecilla Sn, 39008, Santander
University Hospital Virgen Del Rocio S.L.
Digestive system service, Avenida De Manuel Siurot S/n, 41013, Sevilla
University Hospital Son Espases
Digestive service, Carretera Valldemossa 79, 07120, Palma
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | Spain | Acceptable 2024-11-11
|
2024-11-11 |