Iron Deficiency AnemiaPhase 4NCT00802139
Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
A Phase 4 study testing venoferrum(iron sucrose) and Bolgre (Iron acetyl-transferase) in people with Iron Deficiency Anemia, run by JW Pharmaceutical at 3 sites in South Korea.
Trial summary
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- venoferrum(iron sucrose) and Bolgre (Iron acetyl-transferase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2008to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chonnam National Universitiy Hospital
Kwangju
Asan Hospital
Seoul
Catholic University of Korea Kangnam St. Mary's Hospital
Seoul
About this study
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
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
- Conditions
- Iron Deficiency Anemia
- Being tested
- venoferrum(iron sucrose), Bolgre (Iron acetyl-transferase)
- Keywords
- iron deficiency anemia, pregnant women with iron deficiency anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venoferrum(iron sucrose)Drug
administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.
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
| Study group | Role | What they receive |
|---|---|---|
| venoferrum group | Experimental | Not described Receives: Drug: venoferrum(iron sucrose) |
| Bolgre group | Active comparator | Not described Receives: Drug: Bolgre (Iron acetyl-transferase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma hemoglobin level
Measured: 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
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim AM, ph.D, Principal investigator, Asan hospital OB/Gyn unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802139
- Sponsor's protocol ID
- CWP-VNF-402
- Status last verified
- Mar 2012
- First submitted
- 3 Dec 2008
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00802139
- Acronym / sponsor ID
- CWP-VNF-402
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency anemia, pregnant women with iron deficiency anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venoferrum group | Experimental | Drug: venoferrum(iron sucrose) |
| Bolgre group | Active comparator | Drug: Bolgre (Iron acetyl-transferase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venoferrum(iron sucrose)administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level. | Drug | venoferrum group |
| Bolgre (Iron acetyl-transferase)Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks | Drug | Bolgre group |
Primary outcome
Change of plasma hemoglobin level
Time frame: 5 week
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim AM, ph.D principal investigator
Asan hospital OB/Gyn unit
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing venoferrum(iron sucrose) and Bolgre (Iron acetyl-transferase) in people with Iron Deficiency Anemia, run by JW Pharmaceutical at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of plasma hemoglobin level (time frame: 5 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.