Clinical trial • Phase III • Infectious Disease

Clinical trial in Chronic hepatitis D infection

Phase III trial for Chronic hepatitis D infection. 15 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Chronic hepatitis D infection
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
11-09-2025
First CTIS Authorization Date
19-01-2026

Trial design

Phase III trial across 7 sites in Germany, Denmark.

Target Sample Size
15
Trial Duration For Participant
1096

Eligibility

Recruits 15 Vulnerable population not selected; no consent or assent details provided..

Vulnerable Population
Vulnerable population not selected; no consent or assent details provided.

Recruitment

Planned Sample Size
15
Recruitment Window Months
36
Consent Approach
No consent or assent information provided.

Geography

Total Number Of Sites
7
Total Number Of Participants
15

Germany

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
137
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Infectious Diseases
Contact Person Name
Christian Gaebler
Number Of Participants
8

Denmark

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
137
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Odense University Hospital
Department Name
Infectious Diseases
Contact Person Name
Isik Somnuncu Johansen
Contact Person Email
isik.somuncu.johansen@rsyd.dk
Site Name
Region Midtjylland
Department Name
Infectious Diseases
Contact Person Name
Ole Schmeltz Søgaard
Contact Person Email
auh.inf-kfe@rm.dk
Site Name
Rigshospitalet
Department Name
Infectious Diseases
Contact Person Name
Jan Gerstoft
Contact Person Email
jan.gerstoft@regionh.dk
Site Name
Kolding Sygehus
Department Name
Infectious Diseases
Contact Person Name
Lone Wulff Madsen
Contact Person Email
lone.wulff.madsen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Infectious Diseases
Contact Person Name
Karina Kirk
Contact Person Email
kfk@rn.dk
Site Name
Hvidovre Hospital
Department Name
Infectious Diseases
Contact Person Name
Nina Weis
Contact Person Email
nina.weis@regionh.dk

Sponsor

Primary sponsor

Full Name
Region Midtjylland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

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