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

JW Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency Anemia

Treatments: Drug: Bolgre (Iron acetyl-transferase); Drug: venoferrum(iron sucrose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802139

CWP-VNF-402

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

venoferrum group

Experimental group

Treatment:

Drug: venoferrum(iron sucrose)

Bolgre group

Active Comparator group

Treatment:

Drug: Bolgre (Iron acetyl-transferase)