Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
50
Countries
2
Sites
4
Advanced liver fibrosis and/or mild liver cirrhosis
Key facts
- Sponsor
- Alentis Therapeutics AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 25 May 2023 → 30 Oct 2024
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516455-40-00
- EudraCT number
- 2022-002658-20
- ClinicalTrials.gov
- NCT05939947
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced liver fibrosis and/or mild liver cirrhosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10019668 | Hepatic fibrosis | 100000004871 |
| 20.0 | HLT | 10019669 | Hepatic fibrosis and cirrhosis | 10019805 |
| 20.0 | LLT | 10024667 | Liver cirrhosis | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alentis Therapeutics AG
- Sponsor organisation
- Alentis Therapeutics AG
- Address
- Hegenheimermattweg 167a
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Alentis Therapeutics AG
- Contact name
- Clinical Trial Manager
Public contact point
- Organisation
- Alentis Therapeutics AG
- Contact name
- Clinical Trial Manager
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 27 | 2 |
| Slovakia | Ended | 10 | 2 |
| Rest of world
United States
|
— | 13 | — |
Investigational sites
Arensia Exploratory Medicine S.R.L.
Clinical Trial Unit, Strada Banul Antonache 40-44 4th Floor District 1, Sector 1, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Gastroenterologie, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Summit Clinical Research s.r.o.
Clinical Trial Unit, Duklianskych Hrdinov 34, 901 01, Malacky
Summit Clinical Research s.r.o.
Clinical Trial Unit, Nove Mesto, Bardosova 2a, Bratislava
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 |
|---|---|---|---|---|---|
| Romania | 2023-05-25 | 2024-10-29 | 2023-05-25 | 2024-08-05 | |
| Slovakia | 2023-07-11 | 2024-05-16 | 2023-07-11 | 2024-02-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-23 | Romania | Acceptable 2024-10-21
|
2024-10-21 |