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Dose escalating study to evaluate pharmacokinetics, efficacy and safety of apotransferrin in atransferrinemia patients. Estudio de escalada de dosis para evaluar la farmacocinÊtica, la eficacia y la seguridad de apotransferrina, en pacientes con atransferrinemia. - Apotransferrin replacement in atransferrinemia

Dose escalating study to evaluate pharmacokinetics, efficacy and safety of apotransferrin in atransferrinemia patients. Estudio de escalada de dosis para evaluar la farmacocinÊtica, la eficacia y la seguridad de apotransferrina, en pacientes con atransferrinemia. - Apotransferrin replacement in atransferrinemia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017409-13-ES
Enrollment
Unknown
Registered
2010-06-28
Start date
2010-06-30
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atransferrinemia MedDRA version: 12.1 Level: LLT Classification code 10044357 Term: Transferrin increased MedDRA version: 12.1 Level: LLT Classification code 10005620 Term: Blood iron increased MedDRA version: 12.1 Level: LLT Classification code 10002272 Term: Anemia

Interventions

Product Name: apotransferrin Product Code: apotransferrin Pharmaceutical Form: Solution for infusion INN or Proposed INN: Apotransferrin Concentration unit: g/ml gram(s)/millilitre Concentration type:

Sponsors

Sanquin Plasma Products
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Established diagnosis of atransferrinemia, defined as serum levels of transferrin below 40 mg/dl 2. Informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known with allergic reactions against human plasma or plasma products 2. Having detectable anti-IgA antibodies

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the pharmacokinetics, efficacy and safety of apotransferrin replacement therapy;Secondary Objective: To determine the optimal dose regimen;Primary end point(s): The primary efficacy parameters are the concentration of transferrin, ferritin and iron in serum as well as the level of transferrin saturation and total iron binding capacity. Safety and clinical tolerance will be monitored by adverse event surveillance and laboratory measurements.—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026