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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

Tracking Information
First Submitted Date  ICMJE December 3, 2008
First Posted Date  ICMJE December 4, 2008
Last Update Posted Date March 30, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
Change of plasma hemoglobin level [ Time Frame: 5 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
Official Title  ICMJE 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
Brief Summary multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • Drug: venoferrum(iron sucrose)
    administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.
  • 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
Study Arms  ICMJE
  • Experimental: venoferrum group
    Intervention: Drug: venoferrum(iron sucrose)
  • Active Comparator: Bolgre group
    Intervention: Drug: Bolgre (Iron acetyl-transferase)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2010)
58
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2008)
90
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00802139
Other Study ID Numbers  ICMJE CWP-VNF-402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JW Pharmaceutical
Study Sponsor  ICMJE JW Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim AM, ph.D Asan hospital OB/Gyn unit
PRS Account JW Pharmaceutical
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP