Clinical trial to investigate the treatment with apotransferrin of patients with atransferrinemia

• Conditions: Atransferrinemia; MedDRA version: 16.1Level: LLTClassification code 10055212Term: Hypochromic microcytic anemiaSystem Organ Class: 100000004851; MedDRA version: 16.1Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851; MedDRA version: 16.1Level: PTClassification code 10065973Term: Iron overloadSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.1Level: PTClassification code 10044356Term: Transferrin decreasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 16.1Level: PTClassification code 10005620Term: Blood iron increasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2009-017409-13-IT
• Lead Sponsor: Sanquin Blood Supply Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-22
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 6

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: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
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