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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

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