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

Phase 4

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: venoferrum(iron sucrose); Drug: Bolgre (Iron acetyl-transferase)

• Registration Number: NCT00802139
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Primary Completion: 2009-06
• Study Completion: 2010-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
venoferrum group	venoferrum(iron sucrose)	-
Bolgre group	Bolgre (Iron acetyl-transferase)	-

Primary Outcome Measures

Name	Time	Method
Change of plasma hemoglobin level	5 week

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Chonnam National Universitiy Hospital; 🇰🇷 KwangJu, Korea, Republic of

Asan Hospital; 🇰🇷 Seoul, Korea, Republic of

Catholic University of Korea Kangnam St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of