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The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) |
|
| Standard Medical Care (SMC) | Active Comparator | Varied as determined by the Investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose | Drug |
| ||
| Standard Medical Care (SMC) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's). | From Day 0 through 30 days after the last dose of study drug. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals | Norristown | Pennsylvania | 19403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28487769 | Derived | Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13. |
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Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | Intravenous (IV) iron |
| FG001 | Standard Medical Care (SMC) | SMC for postpartum and heavy uterine bleeding subjects with anemia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | Intravenous (IV) iron |
| BG001 | Standard Medical Care (SMC) | SMC for postpartum and heavy uterine bleeding subjects with anemia |
| 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 | Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's). | Posted | Number | participants | From Day 0 through 30 days after the last dose of study drug. |
|
1 year and 5 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) | Intravenous (IV) iron |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark 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 |
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| Drug |
|
| 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 |
|
|
| 6 |
| 996 |
| 9 |
| 996 |
| EG001 | Standard Medical Care (SMC) | SMC for postpartum and heavy uterine bleeding subjects with anemia | 22 | 1,022 | 79 | 1,022 |
| Lymphadenitis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Necrotising Fasciitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Postoperative abscess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Endometritis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | CTCAE (3.0) | Systematic Assessment |
|
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | CTCAE (3.0) | Systematic Assessment |
|
| Uterine hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
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