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Clinical Trials in Germany / NCT01797055
Active, not recruiting Phase 2

Apotransferrin in Atransferrinemia

NCT01797055 · tracked via the Priya Life Science Germany tracker
Sponsor
Prothya Biosolutions
Phase
Phase 2
Started
2010-12
Last updated
2026-09-16

Condition(s) studied

Congenital Atransferrinemia

Investigational drug(s) / intervention(s)

Human apotransferrin

Human apotransferrin: intravenous infusion

Study summary

Atransferrinemia is a very rare disorder, which is caused by a deficiency of the protein transferrin. No regular treatment is available for these patients. The objective of this study is to investigate the pharmacokinetics, efficacy and safety of Apotransferrin replacement therapy in atransferrinemia patients.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Established diagnosis of atransferrinemia, defined as serum levels of transferrin below 40 mg/dl * Informed consent Exclusion Criteria: * Known with allergic reactions against human plasma or plasma products * Having detectable anti-immunoglobulin A antibodies

Primary outcome measure(s)

  • Hemoglobin — 15 year
    Hemoglobin within normal range
  • pharmacokinetics of transferrin — first infusion and year 3
    serum transferrin levels measured on several time points before and after infusion
  • iron overload in organs — 15 years
    Elimination of iron overload (liver, heart)

Trial sites (3)

FacilityCityRegionStatus
Klinikum Aschaffenburg Aschaffenburg Germany
AO San Gerardo Monza Italy
Vall d'Hebron Hospital Barcelona Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01797055 on ClinicalTrials.gov ↗ ← All trials in Germany