Status:
COMPLETED
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Detailed Description
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Eligibility Criteria
Inclusion
- 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
- 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
- Aspartate aminotransferase (AST) or Alanine transaminase( 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT00740246
Start Date
July 1 2005
End Date
May 1 2006
Last Update
April 18 2025
Active Locations (1)
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1
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403