Clinical trial • Phase I • Haematology

TU7710 for Hemophilia A | Hemophilia B

Phase I trial of TU7710 for Hemophilia A | Hemophilia B. None/Not specified-controlled. 21 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Hemophilia A | Hemophilia B
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
19-03-2024
First CTIS Authorization Date
08-07-2024

Trial design

None/Not specified-controlled Phase I trial across 6 sites in Italy, Spain, Bulgaria and others.

Comparator
None/Not specified
Target Sample Size
21

Eligibility

Recruits 21 Vulnerable population not selected; no special consent or assent handling described..

Vulnerable Population
Vulnerable population not selected; no special consent or assent handling described.

Recruitment

Planned Sample Size
21
Recruitment Window Months
30

Geography

Total Number Of Sites
6
Total Number Of Participants
21

Italy

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
739
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Careggi University Hospital
Department Name
Oncologia
Principal Investigator Name
Giancarlo Castaman
Principal Investigator Email
castaman@aou-careggi.toscana.it
Contact Person Name
Giancarlo Castaman

Spain

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
683
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Hematology
Principal Investigator Name
Francisco Javier Lopez Jaime
Principal Investigator Email
franlopezjaime@gmail.com
Contact Person Name
Francisco Javier Lopez Jaime
Contact Person Email
franlopezjaime@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Ana Cid Haro
Principal Investigator Email
cid_ana@gva.es
Contact Person Name
Ana Cid Haro
Contact Person Email
cid_ana@gva.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Ramiro Nuñez Vazquez
Principal Investigator Email
ramirojosenv@gmail.com
Contact Person Name
Ramiro Nuñez Vazquez
Contact Person Email
ramirojosenv@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
03-03-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
435
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
III Department of Clinical Hematology
Principal Investigator Name
Toshko Lissitchkov
Principal Investigator Email
t_lissitchkov@yahoo.com
Contact Person Name
Toshko Lissitchkov
Contact Person Email
t_lissitchkov@yahoo.com

Romania

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
242
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Hematologie
Principal Investigator Name
Criprian Tomuleasa
Principal Investigator Email
office@iocn.ro
Contact Person Name
Criprian Tomuleasa
Contact Person Email
office@iocn.ro

Sponsor

Primary sponsor

Full Name
Tiumbio Co. Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Korea, Republic of

Investigational products

Investigational Product Name
TU7710

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