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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