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.
Male or female patient at least 18 years old at the time of screening
Patients with general iron deficiency anaemia IDA
Patients with serum ferritin levels ≤40 ng/mL inclusive
Patients with haemoglobin (Hb) levels <10 g/dL
Pregnant or breastfeeding patients
Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study (screening - V5).
Severe physical inability, e.g., ASA physical status IV or V.
Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia.
Parallel
Ferric Bepectate IV Injection
DrugFerric Bepectate IV Injection 50 mg iron/mL
Ferric Carboxymaltose Injection [Ferinject]
DrugFerric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
Ferric Carboxymaltose Injection [Injectafer®]
DrugFerric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart
6
Treatment groupsSee each treatment group below.
Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment
The mean change in blood hemoglobin from baseline at week 6 showing non-inferiority between the treatment groups Ferric Bepectate IV Injection (single dose) and Injectafer
Change in hemoglobin comparing one dose Ferric bepectate and two dose Ferinject treatment
The mean change in blood hemoglobin from baseline at week 6 showing non-inferiority between the treatment groups Ferric Bepectate IV Injection (single dose) and Ferinject
Incidence of treatment emergent adverse events
Incidence of treatment emergent adverse events (TEAE) during the 2 hours following the start of infusion
Blood hemoglobin amount
Mean blood hemoglobin at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
Hemoglobin change from baseline
Mean change in blood hemoglobin from baseline to weeks 1, 2, 4 and 6.
Serum iron change from baseline
Mean change in serum iron from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
Serum ferritin change from baseline
Mean change in serum ferritin from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
Pooled data hemoglobin amount
Mean hemoglobin at weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
Pooled data change in hemoglobin
Mean change in hemoglobin from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
Pooled data change in serum iron
Mean change in serum iron from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
Pooled data change in serum ferritin
Mean change in serum ferritin from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
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AFT Pharmaceuticals, Ltd.
Lead sponsor
HungaroTrial
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
