Clinical trial • Phase I • Infectious Disease

Clinical trial in Septic cholestasis

Phase I trial for Septic cholestasis. 48 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Septic cholestasis
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
17-10-2024
First CTIS Authorization Date
15-11-2024

Trial design

Phase I trial across 1 site in Germany.

Target Sample Size
48

Recruitment

Planned Sample Size
48
Recruitment Window Months
11

Geography

Total Number Of Sites
1
Total Number Of Participants
48

Germany

Earliest CTIS Part Ii Submission Date
29-10-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
538
Number Of Sites
1
Number Of Participants
48

Sites

Site Name
Charite Research Organisation GmbH
Contact Person Name
András Maifeld

Sponsor

Primary sponsor

Full Name
SmartDyeLivery GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

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