Clinical trial • Infectious Disease

Transfer Factor TFI for Recurrent respiratory tract infections | Recurrent urinary tract infections | Recurrent herpetic infections

Clinical trial of Transfer Factor TFI for Recurrent respiratory tract infections | Recurrent urinary tract infections | Recurrent herpetic infections.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Recurrent respiratory tract infections | Recurrent urinary tract infections | Recurrent herpetic infections

Key dates

Initial CTIS Submission Date
13-09-2024
First CTIS Authorization Date
08-01-2025

Trial design

Randomised, placebo (placebo-controlled); dose and schedule not specified trial across 3 sites in Czechia.

Randomised
Yes
Comparator
Placebo (placebo-controlled); dose and schedule not specified
Target Sample Size
100
Trial Duration For Participant
183

Eligibility

Recruits 100 Vulnerable population selected; no details on consent or assent handling provided in the record..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided in the record.

Recruitment

Planned Sample Size
100
Recruitment Window Months
13

Geography

Total Number Of Sites
3
Total Number Of Participants
100

Czechia

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
08-01-2025
Processing Time Days
121
Number Of Sites
3
Number Of Participants
100

Sites

Site Name
Nemocnice Na Homolce
Department Name
Oddělení Klinické biochemie, hematologie a imunologie
Contact Person Name
Miroslav Průcha
Contact Person Email
Miroslav.Prucha@homolka.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Ustav klinicke imunologie a alergologie
Contact Person Name
Irena Krcmova
Contact Person Email
Irena.krcmova@fnhk.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
. Depart. Allergology and Clinical Immunology
Contact Person Name
Jaromir Bystron
Contact Person Email
jaromir.bystron@fno.cz

Sponsor

Primary sponsor

Full Name
Aumed a.s.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Czechia

Investigational products

Investigational Product Name
Transfer Factor TFI

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