Ferric Bepectate for Iron-Deficiency Anemia
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to see if a new intravenous iron formulation (Ferric Bepectate IV Injection) can treat adult patients with iron deficiency anemia (IDA) by increasing blood hemoglobin (Hb) as an established formulation (Ferric carboxymaltose). It will also learn about the safety of Ferric Bepectate IV Injection. The main questions it aims to answer are:
* Does hemoglobin increase by the same amount 6 weeks after each treatment?
* What medical problems do participants have when being treated with the drug? Researchers will compare single dose treatment plans of Ferric Bepectate to double dose treatment plans of both Ferric Bepectate and Ferric carboxymaltose.
Participants and researchers will know which drug they are being provided (open-label). Participants will visit the clinic 5 times over 6 weeks for checkups, blood tests and questionaries. The first two visits will be seven days apart and include the two doses of iron treatment.
Who Is on the Research Team?
Ioana Stanescu, Phil.Lic., MSc.
Principal Investigator
AFT Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults (18+) with iron deficiency anemia, low blood iron and hemoglobin levels, weighing at least 35 kg, and with healthy liver and kidney function. Participants must be able to understand the study details and give consent.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Ferric Bepectate IV Injection
- Ferric Carboxymaltose Injection
Trial Overview
The study compares a new IV iron treatment (Ferric Bepectate) to an established one (Ferric Carboxymaltose) in adults with iron deficiency anemia. It looks at how well each raises hemoglobin over 6 weeks using different dosing plans. Both patients and doctors know which drug is given.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
Two dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 1000 mg per dose.
Two dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
Single dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 2000 mg per dose.
Single dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 2000 mg per dose.
Two dose ferric carboxymaltose active comparator treatment for USA and Japan. 50 mg iron/mL. Up to 750 mg per dose.
Two dose ferric carboxymaltose active comparator treatment for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AFT Pharmaceuticals, Ltd.
Lead Sponsor
HungaroTrial
Collaborator
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