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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | 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. |
|
| Ferrous Sulfate tablets | Active Comparator | 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Drug | 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. |
| Measure | Description | 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 |
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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 |
|---|---|---|---|
| 17666600 | Result | 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. | |
| Result | Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008. | ||
| 18928998 |
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1 subject in each group were discontinued from the study prior to dosing due to subject request.
Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Ferrous Sulfate Tablets | 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ferrous Sulfate 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 Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL | Posted | Number | participants | anytime between baseline and end of study or time to intervention |
|
7 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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | 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 | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | mfalone@luitpold.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 |
|---|---|
| C522335 | ferric carboxymaltose |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| Ferrous Sulfate tablets | Drug | 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. |
|
| Result |
| Seid MH, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol. 2008 Oct;199(4):435.e1-7. doi: 10.1016/j.ajog.2008.07.046. |
| Result | Seid MH, Rogers R, Dinh Q. The Safety and Tolerability of Ferric Carboxymaltose in Treating Postpartum Women with Iron Dediciency Anemia. American College of Obstetrics & Gynecology District Meeting 2007. |
| Result | Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Managment 6th Annual Meeting 2007. |
| Result | Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008. |
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Reported Adverse Events | Not Posted | anytime between baseline and end of study or time to intervention | Participants |
| 4 |
| 142 |
| 9 |
| 142 |
| EG001 | Ferrous Sulfate Tablets | 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. | 4 | 147 | 29 | 147 |
| Mitral valve prolapse | Cardiac disorders | CTCAE (3.0) |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) |
|
| Cholecystitis acute | Hepatobiliary disorders | CTCAE (3.0) |
|
| Pyelonephritis | Infections and infestations | CTCAE (3.0) |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Endometritis | Infections and infestations | CTCAE (3.0) |
|
| Pelvic abscess | Infections and infestations | CTCAE (3.0) |
|
| Headache | Nervous system disorders | CTCAE (3.0) |
|
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |