Clinical trial to investigate the treatment with apotransferrin of patients with atransferrinemia
Phase 1
Recruiting
- Conditions
- Congenital atransferrinaemia/ hypotransferrinaemiaMedDRA version: 23.1Level: PTClassification code: 10084860Term: Hypotransferrinaemia Class: 100000004851MedDRA version: 23.0Level: LLTClassification code: 10083978Term: Congenital atransferrinaemia Class: 10010331MedDRA version: 20.0Level: PTClassification code: 10044356Term: Transferrin decreased Class: 100000004848MedDRA version: 21.0Level: PTClassification code: 10065973Term: Iron overload Class: 100000004861MedDRA version: 20.0Level: LLTClassification code: 10055212Term: Hypochromic microcytic anemia Class: 10005329MedDRA version: 21.0Level: PTClassification code: 10005620Term: Blood iron increased Class: 100000004848Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- CTIS2024-515986-33-00
- Lead Sponsor
- Prothya Biosolutions Netherlands B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Established diagnosis of atransferrinemia, defined as serum levels of transferrin below 40 mg/dL, Signed informed consent
Exclusion Criteria
Known with allergic reactions against human plasma or plasma products, Having detectable anti-IgA antibodies, Fertile women unless they take valid contraceptive measures (ITA only)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method