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OpenTrials
Completed

NCT Number: NCT00802139

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

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

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Chonnam National Universitiy Hospital, Kwangju, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

venoferrum(iron sucrose)

Drug

administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.

Bolgre (Iron acetyl-transferase)

Drug

Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks

Primary outcomes

  1. Change of plasma hemoglobin level

    Time frame: 5 week

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 4, 2008
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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