Postpartum Anemia
Conditions
Keywords
anemia, postpartum
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.
Detailed description
This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.
Interventions
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
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 Hgb \< /= 10 g/dL * Agree to practice birth control
Exclusion criteria
* Participation in previous clinical trial of this investigational agent * Known hypersensitivity reaction to active control * Significant vaginal bleeding * History of anemia other than iron deficiency anemia * Anticipated need for surgery during the study * Active severe infection or malignancy * Known positive Hepatitis B antigen of Hepatitis C viral antibody * Known HIV antibodies * Received an investigational drug within 30 days of screening * Alcohol abuse within past 6 months * Hemochromatosis or other iron storage disorders * Significant cardiovascular disease * Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL | anytime between baseline and end of study or time to intervention |
| Reported Adverse Events | anytime between baseline and end of study or time to intervention |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Pre-assignment details
1 subject in each group were discontinued from the study prior to dosing due to subject request.
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. | 142 |
| Ferrous Sulfate Tablets 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. | 147 |
| Total | 289 |
Baseline characteristics
| Characteristic | Ferrous Sulfate Tablets | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 14 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 140 Participants | 128 Participants | 268 Participants |
| Age, Continuous | 26.49 years STANDARD_DEVIATION 5.55 | 26.43 years STANDARD_DEVIATION 6.02 | 26.45 years STANDARD_DEVIATION 5.86 |
| Region of Enrollment United States | 147 participants | 142 participants | 289 participants |
| Sex: Female, Male Female | 147 Participants | 142 Participants | 289 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 | 9 / 142 | 29 / 147 |
| serious Total, serious adverse events | 4 / 142 | 4 / 147 |
Outcome results
Primary
Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
Time frame: anytime between baseline and end of study or time to intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL | 127 participants |
| Ferrous Sulfate Tablets | Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL | 98 participants |
Primary
Reported Adverse Events
Time frame: anytime between baseline and end of study or time to intervention