Apotransferrin in Patients With β-thalassemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2022-03-31

Brief Summary

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The aim of the trial is to study the effect of apotransferrin administration in patients suffering from β-thalassemia intermedia in order to restore the erythropoiesis as reflected by enhanced haemoglobin levels or reduced transfusion dependency.

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Detailed Description

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Conditions

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β-thalassemia Intermedia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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human apotransferrin

Patients will receive an intravenous dose of human apotransferrin every two weeks for 14-18 weeks.

Group Type EXPERIMENTAL

human apotransferrin

Intervention Type BIOLOGICAL

Intravenous infusions

Interventions

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human apotransferrin

Intravenous infusions

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Non-transfusion dependent β-thalassemia intermedia, defined as patients with microcytic anaemia in combination with an elevated HbA2 (\>2.5%) and a haemoglobin of \<6.2 mmol/L, or transfusion dependent β-thalassemia treated with a regular transfusion schedule.
* Age above≥ 17 years.
* Adequate renal and hepatic function tests
* WHO performance 0, 1 or 2.
* Signed informed consent.

Exclusion Criteria

* Known with allergic reactions against human plasma or plasma products.
* Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease).
* Cardiac dysfunction as defined by: myocardial infarction within the last 6 months of study entry, unstable angina, or unstable cardiac arrhythmias.
* Pregnant or lactating females.
* Known with IgA deficiency with anti-IgA antibodies

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No