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

• Conditions: Atransferrinemia; MedDRA version: 12.1Level: LLTClassification code 10044357Term: Transferrin increased; MedDRA version: 12.1Level: LLTClassification code 10005620Term: Blood iron increased; MedDRA version: 12.1Level: LLTClassification code 10002272Term: Anemia

• Registration Number: EUCTR2009-017409-13-ES
• Lead Sponsor: Sanquin Plasma Products

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified