Iron Deficiency AnemiaPhase 2NCT03485053
A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia
A Phase 2 study testing IOP Injection / MPB-1514 in people with Iron Deficiency Anemia, run by MegaPro Biomedical Co. Ltd. at 8 sites in United States.
Trial summary
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- IOP Injection / MPB-1514
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Nov 2018to 31 Aug 2021
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject ≥ 18 years.
- Subject with IDA but not secondary to any malignancy or renal failure requiring dialysis.
- Hb levels <11.0 g/dL, Ferritin levels <200 ng/dL, Transferrin saturation (TSAT) < 20% at the Screening Visit.
- Subject must have the ability to provide written, personally signed, and dated informed consent to participate in the study.
- Subject must have an understanding, ability, and willingness to comply fully with study procedures and restrictions and to be available for clinic visits and follow-up procedures.
- Female subject of child-bearing potential who is sexually active must use an effective method of birth control for at least one month prior to screening and agree to use an effective method of birth control until completion of participation in the study.
Who cannot join
- Subject with known hemochromatosis, thalassemia, hemolytic anemia, receive red blood cell or whole blood transfusions within 90 days prior to enrollment.
- Subject with a history of intravascular hemolysis.
- Subject receiving any erythropoiesis-stimulating agent (ESA) therapy within 4 weeks prior to screenin.
- Subject with a known sensitivity to any i.v. iron formulation
- Subject with C-reactive protein > 20 mg/dL.
- Subject with HBV, HCV, HIV.
Show all 15Show fewer
- Subject with known malignancy or severe renal failure requiring dialysis.
- Subject with a recent (within 1 year of study drug administration) drug or alcohol abuse (including cannabis products) as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse.
- Subject averages an intake of more than 21 units of alcohol per week (≥ 3 drinks per day) for men and 14 units of alcohol per week (≥ 2 drinks per day) for women (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
- Subject who has smoked or used smoking cessation or nicotine containing products (including but not limited to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months of the first dose of study drug.
- Subject with any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
- Subject with psychiatric disorder precluding the understanding of information on study related topics or giving informed consent.
- Subject who has received another investigational agent within 4 weeks prior to screening.
- Subject undergoing major surgery or physical trauma within 90 days or with major burn injury covering > 20% of total body surface area.
- Female subject who is pregnant or breast feeding.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
North America Research Institute
Azusa, California, 91702
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
North Shore University Hospital Lab
Manhasset, New York, 11030
Valley Renal Medical Group
Northridge, California, 91324
Southwest Houston Research Ltd.
San Antonio, Texas, 78227
Clinical Research Development Associates
Springfield Gardens, New York, 11413
Whittier Internal Medicine and Nephrology Medical Group
Whittier, California, 90602
About this study
Official title: 2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).
Read the detailed description
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.
- Conditions
- Iron Deficiency Anemia
- Being tested
- IOP Injection / MPB-1514
- 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.
IOP Injection / MPB-1514Drug
Dilute with 5% Dextrose solution (D5W)
| Study group | Role | What they receive |
|---|---|---|
| IOP Injection / MPB-1514 | Experimental | Administered IV infusion Receives: Drug: IOP Injection / MPB-1514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference in Hb from baseline
Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing
Measured: on Day 28
Secondary outcomes (4)
The number of subjects with treatment-related serious adverse events
Safety will be assessed using the incidence of treatment-related serious adverse events
Measured: Day 0 to Day 28
Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration
Measurement of peak plasma concentration after dosing (Cmax)
Measured: 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)
Measured: 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)
Measured: pre-dose to post-dose 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start29 Nov 2018
- Primary completion30 Sep 2020
- Study completion31 Aug 2021
Why it stopped: Sponsor terminate the trial and will conduct a phase 2b clinical trial further
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Fishbane, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485053
- Sponsor's protocol ID
- IOP-CT-004
- Status last verified
- Oct 2021
- First submitted
- 20 Mar 2018
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia
- ClinicalTrials.gov ID
- NCT03485053
- Acronym / sponsor ID
- IOP-CT-004
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminate the trial and will conduct a phase 2b clinical trial further
- Enrolment
- 49 participants (actual)
- Lead sponsor
- MegaPro Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 2 Apr 2018 (actual)
- 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.
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOP Injection / MPB-1514 | Experimental | Drug: IOP Injection / MPB-1514Administered IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject ≥ 18 years.
- Subject with IDA but not secondary to any malignancy or renal failure requiring dialysis.
- Hb levels <11.0 g/dL, Ferritin levels <200 ng/dL, Transferrin saturation (TSAT) < 20% at the Screening Visit.
- Subject must have the ability to provide written, personally signed, and dated informed consent to participate in the study.
- Subject must have an understanding, ability, and willingness to comply fully with study procedures and restrictions and to be available for clinic visits and follow-up procedures.
Key exclusion criteria (15 listed)
- Subject with known hemochromatosis, thalassemia, hemolytic anemia, receive red blood cell or whole blood transfusions within 90 days prior to enrollment.
- Subject with a history of intravascular hemolysis.
- Subject receiving any erythropoiesis-stimulating agent (ESA) therapy within 4 weeks prior to screenin.
- Subject with a known sensitivity to any i.v. iron formulation
- Subject with C-reactive protein > 20 mg/dL.
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 |
|---|---|---|
| IOP Injection / MPB-1514Dilute with 5% Dextrose solution (D5W) | Drug | IOP Injection / MPB-1514 |
Primary outcome
The mean difference in Hb from baseline
Time frame: on Day 28
Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing
4 secondary outcomes
The number of subjects with treatment-related serious adverse events
Time frame: Day 0 to Day 28
Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration
Time frame: pre-dose to post-dose 24 hours
Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time
Time frame: pre-dose to post-dose 24 hours
Pharmacokinetic analysis of IOP Injection: Half-life in Plasma
Time frame: pre-dose to post-dose 24 hours
Results and safety
The study was stopped early (reason given: Sponsor terminate the trial and will conduct a phase 2b clinical trial further). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Steven Fishbane, MD principal investigator
North Shore University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IOP Injection / MPB-1514 in people with Iron Deficiency Anemia, run by MegaPro Biomedical Co. Ltd. at 8 sites in United States.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Sponsor terminate the trial and will conduct a phase 2b clinical trial further). Results are not available in the source record.
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?
The mean difference in Hb from baseline (time frame: on Day 28). 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 28 Oct 2021.