A Prospective, Randomized, Multi-centered Trial to Compare the Efficacy and Safety of Intravenous Iron Sucrose (Venoferrum®) With Oral Iron Acetyl-transferrin Hydroglycerin (Bolgre®) in Pregnant Women With Iron Deficiency Anemia

JW Pharmaceutical3 sites in 1 country58 target enrollmentFebruary 2008

Overview

multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

October 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

JW Pharmaceutical

Responsible Party

Sponsor

•Patients who have participated in another clinical study in recent 3 months
•Patients who are prone to acute hemorrhage during pregnancy
•Patients who have shown intolerance to iron therapy
•Hemolytic anemia, hemoglobinopathies (thalassemia, sickle cell)
•Bleeding tendency, hypersplenism
•Chronic heart failure, Class II-IV heart disease, uncontrolled arterial hypertension (DBP ≥ 115mmHg), deep vein thrombosis, thrombocytosis, chronic renal disease
•Severe renal failure patients (2.5 times or more higher plasma creatinine level than high limit of normal state)
•Patients with severe liver dysfunction (2.5 times or more higher AST or ALT than high limit of normal state)
•Patients with doubled or more CK level than high limit of normal state
•Patients who are regarded as ineligible for this study by investigator

Intervention: venoferrum(iron sucrose)

Intervention: Bolgre (Iron acetyl-transferase)

Change of plasma hemoglobin level

Time Frame: 5 week

Target Hb achievement rate(11g/dL), Transferrin saturation(%), Ferritin(ng/mL), TIBC(ug/dL), MCV(fl), MCH(pg) and change in reticulocyte counts(5 week)