A Phase 2 interventional study of IOP Injection / MPB-1514 in Iron Deficiency Anemia, sponsored by MegaPro Biomedical Co. Ltd.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by MegaPro Biomedical Co. Ltd. · Phase 2, Interventional, and Treatment
Among 133 studies in Anemia, Iron-Deficiency with a site in United States — 17 open to participants now, 20 under way, 6 of them phase 3. Anemia, Iron-Deficiency · United States.
Among the 133 studies in Anemia, Iron-Deficiency with a site in United States, this one is the 61st largest by enrollment of the 120 interventional ones, is one of 10 that started in 2018, is one of 11 in phase 2, and was the 75th registered.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →17 of the 133 studies in Anemia, Iron-Deficiency with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →133 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 10 started in 2018.
Median enrollment 50 across the 120 interventional studies, 110 across the 12 observational. Of the 104 that completed or were terminated, 56 (54%) have results posted.
45 of 133 have an industry lead sponsor. The 10 most frequent:
MegaPro Biomedical Co. Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
MegaPro Biomedical Co. Ltd. has 1 study filed under Anemia, Iron-Deficiency — fewer than ten, so there is no comparison to draw.
4 of the studies in Anemia, Iron-Deficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05462704Phase 3Women and Infants Hospital of Rhode IslandIntravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy | 2027-03-30 |
| NCT06146608Cornell UniversityHeme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption | 2027-01-14 |
| NCT05340465University of WashingtonDarbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants | 2027-01-30 |
| NCT07816601AdventHealthDonor Breast Milk 2 | 2027-11 |
Among the 133 studies in Anemia, Iron-Deficiency with a site in United States, from their registry updates:
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).
The Phase II study is to establish the maximum tolerated dose of i.v. IOP Injection (MPB-1514) in Part 1 and to evaluate the safety and efficacy of the maximally tolerated dose of IOP Injection with different infusions schemes in Part 2.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered IV infusion
Drug: IOP Injection / MPB-1514
Dilute with 5% Dextrose solution (D5W)
The mean difference in Hb from baseline
Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing
Time frame: on Day 28
The number of subjects with treatment-related serious adverse events
Safety will be assessed using the incidence of treatment-related serious adverse events
Time frame: Day 0 to Day 28
Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration
Measurement of peak plasma concentration after dosing (Cmax)
Time frame: pre-dose to post-dose 24 hours
Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time
Measurement of area under the plasma concentration versus time curve (AUC)
Time frame: pre-dose to post-dose 24 hours
Pharmacokinetic analysis of IOP Injection: Half-life in Plasma
Measurement of half-life of study drug in plasma after dosing (T1/2)
Time frame: pre-dose to post-dose 24 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Sep 2020, 22 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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MegaPro Biomedical Co. Ltd.