Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin

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

Official Title
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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

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: venoferrum(iron sucrose)
* Drug: Bolgre (Iron acetyl-transferase)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 32nd weeks pregnant women aged over 18 years Women who have Hb level of more than 10.0g/dL a week before study initiation Patients who agree to participate in this study in writing Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: venoferrum group<br> | Drug: venoferrum(iron sucrose)<br>* administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.<br>|
| Active Comparator: Bolgre group<br> | Drug: Bolgre (Iron acetyl-transferase)<br>* Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of plasma hemoglobin level |  | 5 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia, pregnant women with iron deficiency anemia