Anemia
Conditions
Keywords
Anemia, postpartum, Postpartum anemia
Brief summary
This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.
Detailed description
This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.
Interventions
DRUGOral iron tablets
325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
DRUGVIT-45
A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female Subjects able to give consent * Post partum patients * Baseline Hbg\< /= 10 * Agree to practice birth control * Demonstrate willingness to comply with protocol restrictions
Exclusion criteria
* Known hypersensitivity reaction to oral or IV iron (VIT-45) * Documented history of discontinuing oral iron * Significant bleeding * History of anemia other that iron deficiency anemia * Severe Psychiatric disorders * Active severe infection * Known Hepatitis B antigen or Hep C viral antibody or active hepatitis * Known HIV antibody * Received investigational product within 30 days * Alcohol abuse * Hemochromatosis or other iron storage disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin | anytime between baseline and the end of study or time to intervention |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Pre-assignment details
8 subjects randomized to VIT-45 were discontinued prior to dosing due to subject request (3 subjects), lost to follow-up (2 subjects), 'other reasons' (2 subjects), and physician decision (1 subject). The 1 subject that was randomized to oral iron was lost to follow-up.
Participants by arm
| Arm | Count |
|---|---|
| VIT-45 A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered | 174 |
| Oral Iron Tablets 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 | 178 |
| Total | 352 |
Baseline characteristics
| Characteristic | Oral Iron Tablets | VIT-45 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 15 Participants | 31 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 162 Participants | 159 Participants | 321 Participants |
| Age, Continuous | 26.03 years STANDARD_DEVIATION 5.95 | 26.93 years STANDARD_DEVIATION 6.36 | 26.41 years STANDARD_DEVIATION 6.17 |
| Region of Enrollment United States | 178 participants | 174 participants | 352 participants |
| Sex: Female, Male Female | 178 Participants | 174 Participants | 352 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 174 | 61 / 178 |
| serious Total, serious adverse events | 4 / 174 | 4 / 178 |
Outcome results
Primary
Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
Time frame: anytime between baseline and the end of study or time to intervention
Population: Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being \<11.0 g/dL
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIT-45 | Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin | 162 participants |
| Oral Iron Tablets | Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin | 159 participants |