Efficacy and Safety Study of Iron Sucrose and Oral Iron A... | NCT00802139

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

NCT00802139

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Mar 30, 2012Estimated

Enrollment

58Actual

Phase

Phase 4

Conditions

Iron Deficiency Anemia

Interventions

venoferrum(iron sucrose)
Bolgre (Iron acetyl-transferase)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Oct 2010Actual

First Submitted Date

Dec 3, 2008

First Submission Date that Met QC Criteria

Dec 3, 2008

First Posted Date

Dec 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2012

Last Update Posted Date

Mar 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
venoferrum group	Experimental		Drug: venoferrum(iron sucrose)
Bolgre group	Active Comparator		Drug: Bolgre (Iron acetyl-transferase)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
venoferrum(iron sucrose)	Drug	administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.	venoferrum group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of plasma hemoglobin level		5 week

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim AM, ph.D	Asan hospital OB/Gyn unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National Universitiy Hospital		Kwangju			South Korea
Asan Hospital

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided