Back to resultsSafety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VIT-45
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility 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
Sites / Locations
- Luitpold Pharmaceuticals
Outcomes
Primary Outcome Measures
Safety and Tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00740246
Brief Title
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VIT-45
Primary Outcome Measure Information:
Title
Safety and Tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Learn more about this trial
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
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