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

March 28, 2012 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • KwangJu, Korea, Republic of
        • Chonnam National Universitiy Hospital
      • Seoul, Korea, Republic of
        • Asan hospital
      • Seoul, Korea, Republic of
        • Catholic University of Korea Kangnam St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of plasma hemoglobin level
Time Frame: 5 week
5 week

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 5 week
5 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Kim AM, ph.D, Asan hospital OB/Gyn unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimate)

December 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWP-VNF-402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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