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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00802139
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: venoferrum(iron sucrose) Drug: Bolgre (Iron acetyl-transferase) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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




Primary Outcome Measures :
  1. Change of plasma hemoglobin level [ Time Frame: 5 week ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802139


Locations
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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, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
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Principal Investigator: Kim AM, ph.D Asan hospital OB/Gyn unit

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Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00802139    
Other Study ID Numbers: CWP-VNF-402
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012
Keywords provided by JW Pharmaceutical:
iron deficiency anemia
pregnant women with iron deficiency anemia
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics