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This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.
This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIT-45 | Experimental | 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 |
|
| Oral iron tablets | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral iron tablets | Drug | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals | Norristown | Pennsylvania | 19403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007. | ||
| Result | Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007. | ||
| 17666600 | Derived | Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18. |
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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.
Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Oral Iron Tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin | 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 | Posted | Number | participants | anytime between baseline and the end of study or time to intervention |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripartum cardiomyopathy | Pregnancy, puerperium and perinatal conditions | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Tokars | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | mtokars@lpicrd.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| C020748 | ferrous sulfate |
| C522335 | ferric carboxymaltose |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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|
| VIT-45 | Drug | 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 |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 4 |
| 174 |
| 40 |
| 174 |
| EG001 | 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 | 4 | 178 | 61 | 178 |
| Cardiac failure | Cardiac disorders | CTCAE (3.0) |
|
| Postoperative infection | Infections and infestations | CTCAE (3.0) |
|
| Appendicitis | Infections and infestations | CTCAE (3.0) |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) |
|
| Cardiac failure congestive | Cardiac disorders | CTCAE (3.0) |
|
| Thrombophlebitis | Vascular disorders | CTCAE (3.0) |
|
| Major depression | Psychiatric disorders | CTCAE (3.0) |
|
| Cholelithiasis | Hepatobiliary disorders | CTCAE (3.0) |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Headache | Nervous system disorders | CTCAE (3.0) |
|
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| D008670 |
| Metals |