Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
43
Countries
4
Sites
10
Primary Sclerosing Cholangitis (PSC)
Key facts
- Sponsor
- Dr. Falk Pharma GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 20 Jul 2023 → 13 Dec 2024
- Decision date (initial)
- 2023-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507027-37-00
- EudraCT number
- 2022-000261-40
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary Sclerosing Cholangitis (PSC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10036732 | Primary sclerosing cholangitis | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dr. Falk Pharma GmbH
- Sponsor organisation
- Dr. Falk Pharma GmbH
- Address
- Leinenweberstrasse 5, Hochdorf Hochdorf
- City
- Freiburg Im Breisgau
- Postcode
- 79108
- Country
- Germany
Scientific contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- CTIS – Scientific Request, Dr. Falk Pharma GmbH
Public contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- Clinical Research and Development, Dr. Falk Pharma GmbH
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 2 |
| Finland | Ended | 8 | 1 |
| Germany | Ended | 16 | 6 |
| Norway | Ended | 5 | 1 |
| Rest of world
United Kingdom
|
— | 10 | — |
Investigational sites
Medical University Of Graz
Center for Medical Research, CTU - Clinical Trials Unit, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University of Vienna
Klin. Abteilung für Gastroenterologie und Hepatologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Universitaetsklinikum Tuebingen AöR
Innere Medizin 1, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Medizinische Hochschule Hannover
Zentrum für Klinische Studien, Feodor-Lynen-Strasse 15, Gross Buchholz, Hanover
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik, Abteilung Klinische Pharmakologie & Pharmakoepidemiologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Medizinische Klinik 1, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Medical Center - University Of Freiburg
Klinik für Innere Medizin II, Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
SocraTec R&D Concepts in Drug Research and Development GmbH
NA, Mainzerhofplatz 14, Erfurt-Altstadt, Erfurt
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 |
|---|---|---|---|---|---|
| Austria | 2023-07-27 | 2024-10-16 | 2023-11-06 | 2024-10-16 | |
| Finland | 2024-08-20 | 2024-10-31 | 2024-10-07 | 2024-10-31 | |
| Germany | 2023-07-20 | 2024-11-29 | 2023-09-11 | 2024-11-29 | |
| Norway | 2024-08-15 | 2024-11-01 | 2024-10-14 | 2024-11-01 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-19 | Germany | Acceptable 2023-11-28
|
2023-12-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-20 | Germany | Acceptable 2024-03-25
|
2024-03-26 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-04-09 | Acceptable 2024-03-25
|
2024-06-10 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-04-18 | Acceptable 2024-03-25
|
2024-07-04 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-09 | Acceptable 2024-03-25
|
2024-07-09 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-11 | Germany | Acceptable 2024-09-10
|
2024-09-11 |