Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

• Phase: Phase 3

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals

Criteria

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