Clinical trial • Phase I • Haematology

Clinical trial in Familial polycythemia (EPO gene mutation)

Phase I trial for Familial polycythemia (EPO gene mutation). open-label, none/not specified-controlled. 4 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Familial polycythemia (EPO gene mutation)
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
30-04-2025
First CTIS Authorization Date
08-07-2025

Trial design

open-label, none/not specified-controlled Phase I trial across 2 sites in France.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
4

Eligibility

Recruits 4 No vulnerable population selected; consent or assent handling not described..

Vulnerable Population
No vulnerable population selected; consent or assent handling not described.

Recruitment

Planned Sample Size
4
Recruitment Window Months
19

Geography

Total Number Of Sites
2
Total Number Of Participants
4

France

Earliest CTIS Part Ii Submission Date
16-06-2025
Latest Decision Or Authorization Date
08-07-2025
Processing Time Days
22
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Centre Hospitalier de Macon
Department Name
Médecine Interne
Principal Investigator Name
Thibault MAILLET
Principal Investigator Email
thmaillet@ch-macon.fr
Contact Person Name
Thibault MAILLET
Contact Person Email
thmaillet@ch-macon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie
Principal Investigator Name
Sabine BRECHIGNAC
Principal Investigator Email
Sabine.brechignac@aphp.fr
Contact Person Name
Sabine BRECHIGNAC
Contact Person Email
Sabine.brechignac@aphp.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Dijon
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

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