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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802139
• Other study ID #: CWP-VNF-402
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2008
• Last updated: March 28, 2012
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: March 2012
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• venoferrum(iron sucrose)
administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.
• Bolgre (Iron acetyl-transferase)
Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National Universitiy Hospital	KwangJu
Korea, Republic of	Asan Hospital	Seoul
Korea, Republic of	Catholic University of Korea Kangnam St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of plasma hemoglobin level		5 week	No
Secondary	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	No