Clinical trial • Phase III • Haematology

petadeferitrin for Iron overload | Thalassemia (beta) | Transfusion-dependent myelodysplastic syndrome | Haemolysis

Phase III trial of petadeferitrin for Iron overload | Thalassemia (beta) | Transfusion-dependent myelodysplastic syndrome | Haemolysis.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Iron overload | Thalassemia (beta) | Transfusion-dependent myelodysplastic syndrome | Haemolysis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-02-2026
First CTIS Authorization Date
07-04-2026

Trial design

None/Not specified-controlled Phase III trial across 1 site in Netherlands.

Comparator
None/Not specified
Target Sample Size
18

Eligibility

Recruits 18 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling are provided in the record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling are provided in the record.

Recruitment

Planned Sample Size
18
Recruitment Window Months
2

Geography

Total Number Of Sites
1
Total Number Of Participants
18

Netherlands

Earliest CTIS Part Ii Submission Date
31-03-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
37
Number Of Sites
1
Number Of Participants
18

Sites

Site Name
Pharmaceutical Research Associates Group B.V.
Department Name
Program Management
Contact Person Name
Jart Oosterhaven
Contact Person Email
Jart.Oosterhaven@iconplc.com
Number Of Participants
18

Sponsor

Primary sponsor

Full Name
Pharmacosmos A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
petadeferitrin
Active Substance
petadeferitrin
Modality
Small molecule
Authorisation Status
Investigational

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