Clinical trial • Not applicable • Infectious Disease|Other

DORNASE ALFA for Pleural empyema

Not applicable trial of DORNASE ALFA for Pleural empyema.

Overview

Trial Therapeutic Area
Infectious Disease|Other
Trial Disease
Pleural empyema
Trial Stage
Not applicable
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
13-05-2024
First CTIS Authorization Date
26-06-2024

Trial design

Randomised, vats (video-assisted thoracoscopic surgery) — surgical control (no drug dose specified). Not applicable trial across 4 sites in Denmark.

Randomised
Yes
Comparator
VATS (video-assisted thoracoscopic surgery) — surgical control (no drug dose specified).
Target Sample Size
184

Eligibility

Recruits 184 adults.

Inclusion criteria

  • {"criterion_text":"- see protocol"}

Exclusion criteria

  • {"criterion_text":"- see protocol"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- see protocol","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- see protocol","definition_or_measurement_approach":""}
  • {"endpoint_text":"- see protocol","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
184
Recruitment Window Months
60

Geography

Total Number Of Sites
4
Total Number Of Participants
184

Denmark

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
6
Number Of Sites
4
Number Of Participants
184

Sites

Site Name
Aalborg University Hospital
Department Name
Lungemedicinsk
Contact Person Name
Rana Bibi
Contact Person Email
rabi@rn.dk
Site Name
Rigshospitalet
Department Name
Lungemedicinsk
Contact Person Name
Zaigham Saghir
Contact Person Email
zaigham.saghir@regionh.dk
Site Name
Odense University Hospital
Department Name
J
Contact Person Name
Christian Laursen
Contact Person Email
Christian.B.Laursen@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
T
Contact Person Name
Thomas Christensen
Contact Person Email
tdc@clin.au.dk

Sponsor

Primary sponsor

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

Third parties

  • {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"codes: 1,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
DORNASE ALFA
Active Substance
DORNASE ALFA
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAPLEURAL USE
Route
INTRAPLEURAL USE
Maximum Dose
10 mg daily; 30 mg total
Investigational Product Name
ALTEPLASE
Active Substance
ALTEPLASE
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAPLEURAL USE
Route
INTRAPLEURAL USE
Maximum Dose
20 mg daily; 60 mg total
Combination Treatment
Yes

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