Back to resultsEfficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
venoferrum(iron sucrose)
Bolgre (Iron acetyl-transferase)
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia, pregnant women with iron deficiency anemia
Eligibility 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
Sites / Locations
- Chonnam National Universitiy Hospital
- Asan Hospital
- Catholic University of Korea Kangnam St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
venoferrum group
Bolgre group
Arm Description
Outcomes
Primary Outcome Measures
Change of plasma hemoglobin level
Secondary Outcome Measures
Target Hb achievement rate(11g/dL), Transferrin saturation(%), Ferritin(ng/mL), TIBC(ug/dL), MCV(fl), MCH(pg) and change in reticulocyte counts
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00802139
Brief Title
Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
iron deficiency anemia, pregnant women with iron deficiency anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
venoferrum group
Arm Type
Experimental
Arm Title
Bolgre group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
venoferrum(iron sucrose)
Intervention Description
administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.
Intervention Type
Drug
Intervention Name(s)
Bolgre (Iron acetyl-transferase)
Intervention Description
Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks
Primary Outcome Measure Information:
Title
Change of plasma hemoglobin level
Time Frame
5 week
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim AM, ph.D
Organizational Affiliation
Asan hospital OB/Gyn unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National Universitiy Hospital
City
KwangJu
Country
Korea, Republic of
Facility Name
Asan Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic University of Korea Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
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