Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIT-45 on Day 0, then Placebo on Day 7 | Experimental | Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Day 7: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. |
|
| Placebo on Day 0, then VIT-45 on Day 7 | Experimental | Day 0: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIT-45 | Drug | 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period | Number of participants with any treatment-emergent adverse events experienced by participants. The 7-day study period for Study Period 1 ended with the initiation of dosing for Study Period 2. The 7-day study period fo Study Period 2 ended with the completion of Day 14 procedures. | Day 0 to 7 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Bregman, MD | American Regent, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals | Norristown | Pennsylvania | 19403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Seid MH, Valaoras TG, Barish CF, Dinh Q. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 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 Management 2007. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hospitals and medical clinics
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VIT-45/Placebo | VIT-45 (15 mg/kg up to a maximum of 1000 mg) given on Day 0. After a washout period of 1 week, they then received Placebo on Day 7 |
| FG001 | Placebo/VIT-045 | Placebo given on Day 0. After a washout period of 1 week, they then received VIT-45 (15 mg/kg up to a maximum of 1000 mg) given on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: All subjects who received at least 1 dose of randomized study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VIT-45 | VIT-45 given on Day 0 and Placebo on Day 7. For assessment purposes, this arm included all subjects who received VIT-45 at Day 0 and Day 7. Also included in this assessment was 12 pharmacokinetic (PK) patients. The PK portion of the study was open-label, not part of the cross-over design, where subjects received 1 unblinded dose of VIT-45 at Day 0. Select sites participated and subjects were enrolled if they agreed to the extra blood draws. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period | Number of participants with any treatment-emergent adverse events experienced by participants. The 7-day study period for Study Period 1 ended with the initiation of dosing for Study Period 2. The 7-day study period fo Study Period 2 ended with the completion of Day 14 procedures. | At Least 1 Treatment-Emergent Adverse Event | Posted | Number | participants | Day 0 to 7 |
|
7 days
594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Not provided
| 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 on Day 0 or Day 7 | Participants received VIT-45 on either Day 0 or Day 7 (a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A Falone | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | 844 | mfalone@americanregent.com |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously |
|
| Selection Criteria/Study Compliance |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Withdrawn By Site Due To non-compliance |
|
| Discontinued Due To Hurricane Related Issue |
|
| Unable To Perform Venipuncture For Day 7, Day 14 Labs, and Day 7 Infusion |
|
| Unable To Comply With Study Visits |
|
| Unable to Access Vein |
|
| Early Term - Patient could not return for second infusion due to Thanksgiving Holiday |
|
| BG001 | Placebo | Placebo given on Day 0 and VIT-45 on Day 7. For assessment purposes, this arm included all subjects who received Placebo at Day 0 and Day 7. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 584 |
| 2 |
| 584 |
| 31 |
| 584 |
| EG001 | Placebo on Day 0 or Day 7 | Participants received Placebo on Day 0 or Day 7 (for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously) | 0 | 569 | 4 | 569 | 19 | 569 |
| Intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diabetes mellitus non-insulin dependent | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Endometritis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
Not provided