Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/15/2017 |
| Start Date: | June 2005 |
A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the
treatment of Iron Deficiency Anemia
treatment of Iron Deficiency Anemia
Inclusion Criteria:
- Subjects > or = 18 years of age and able to give informed consent
- Historical laboratory Hgb indicative of anemia within 3 months prior to screening
visit
- Screening Visit laboratory Hgb indicative of anemia
- Screening Visit ferritin indicative of iron deficiency anemia
Exclusion Criteria:
- Known hypersensitivity to VIT-45
- Previously received VIT-45
- Parenteral iron in the 4 weeks prior to screening
- Chronic or serious active infection
- Malignancy history
- AST or ALT greater than the upper limit of normal
- Anticipated need for surgery or initiation of dialysis during the study
- Pregnant or sexually active females who are not willing to use an effective form of
birth control
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