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TerminatedNCT03485053Updated Oct 28, 2021

A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia

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

Why this study was terminated
Sponsor terminate the trial and will conduct a phase 2b clinical trial further
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject ≥ 18 years.
  2. Subject with IDA but not secondary to any malignancy or renal failure requiring dialysis.
  3. Hb levels \<11.0 g/dL, Ferritin levels \<200 ng/dL, Transferrin saturation (TSAT) \< 20% at the Screening Visit.
  4. Subject must have the ability to provide written, personally signed, and dated informed consent to participate in the study.
  5. 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.
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subject with known hemochromatosis, thalassemia, hemolytic anemia, receive red blood cell or whole blood transfusions within 90 days prior to enrollment.
  2. Subject with a history of intravascular hemolysis.
  3. Subject receiving any erythropoiesis-stimulating agent (ESA) therapy within 4 weeks prior to screenin.
  4. Subject with a known sensitivity to any i.v. iron formulation
  5. Subject with C-reactive protein > 20 mg/dL.
  6. Subject with HBV, HCV, HIV.
  7. Subject with known malignancy or severe renal failure requiring dialysis.
  8. 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.
  9. 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).
  10. 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.
  11. 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.
  12. Subject with psychiatric disorder precluding the understanding of information on study related topics or giving informed consent.
  13. Subject who has received another investigational agent within 4 weeks prior to screening.
  14. Subject undergoing major surgery or physical trauma within 90 days or with major burn injury covering > 20% of total body surface area.
  15. Female subject who is pregnant or breast feeding.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    IOP Injection / MPB-1514

    Administered IV infusion

    Drug: IOP Injection / MPB-1514

Interventions

  • DrugIOP Injection / MPB-1514

    Dilute with 5% Dextrose solution (D5W)

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

06

Study locations

8 sites
  • North America Research Institute
    Azusa, California 91702, United States
  • Valley Renal Medical Group
    Northridge, California 91324, United States
  • Whittier Internal Medicine and Nephrology Medical Group
    Whittier, California 90602, United States
  • South Florida Research Institute
    Lauderdale Lakes, Florida 33313, United States
  • North Shore University Hospital Lab
    Manhasset, New York 11030, United States
  • Clinical Research Development Associates
    Springfield Gardens, New York 11413, United States
  • Northeast Clinical Research Center
    Bethlehem, Pennsylvania 18017, United States
  • Southwest Houston Research Ltd.
    San Antonio, Texas 78227, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03485053
Lead sponsor
MegaPro Biomedical Co. Ltd.
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Nov 29, 2018
Primary completion
Sep 30, 2020
Completion
Aug 31, 2021
Last update
Oct 28, 2021

Study contacts

Steven Fishbane, MD
principal investigator · North Shore University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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