AFT Pharmaceuticals, Ltd.
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.
Iron is essential for the normal functioning of a human body. Iron deficiency anemia (IDA) occurs when blood lacks adequate healthy red blood cells, preventing adequate distribution of oxygen throughout the tissue of the body. IDA, if left uncorrected, may result in complications such as extreme fatigue, weakness, chest pain, shortness of breath, irregular heartbeats or even heart failure in some cases, in addition to reducing the overall quality of life of a patient. Iron supplementation can effectively treat IDA. An iron-rich diet is known to enhance iron levels, however supplementation is…
Inclusion Criteria: 1. Male or female patient at least 18 years old at the time of screening 2. Patients with general iron deficiency anaemia IDA 3. Patients with serum ferritin levels ≤40 ng/mL inclusive 4. Patients with haemoglobin (Hb) levels \<10 g/dL 5. Patients ≥ 35 kg body weight 6. The patient has adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum creatini…
Ferric Bepectate IV Injection 50 mg iron/mL
Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart