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

NCT00802139 | Completed Phase 4 DMC

• 1 other identifier: CWP-VNF-402
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Iron Deficiency Anemia

Keywords

iron deficiency anemia; pregnant women with iron deficiency anemia

Outcome Measures

Primary Outcomes (1)

• Change of plasma hemoglobin level

  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

  5 week

Study Arms (2)

venoferrum group

EXPERIMENTAL

Drug: venoferrum(iron sucrose)

Bolgre group

ACTIVE COMPARATOR

Drug: Bolgre (Iron acetyl-transferase)

Interventions

venoferrum(iron sucrose) DRUG

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

venoferrum group

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

Bolgre group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (3)

Chonnam National Universitiy Hospital

Kwangju, South Korea

Location

Asan Hospital

Seoul, South Korea

Location

Catholic University of Korea Kangnam St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Kim AM, ph.D

  Asan hospital OB/Gyn unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2010
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

KR (3)