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Last Updated: January 28, 2020

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CLINICAL TRIALS PROFILE FOR IRON DEXTRAN

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505(b)(2) Clinical Trials for Iron Dextran

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01067547 A Trial of Iron Replacement in Patients With Iron Deficiency. Completed Richard Fedorak Phase 4 2010-03-01 Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Iron Dextran

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000684 Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study. Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously
NCT00000690 Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
NCT00001009 A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without persistent generalized lymphadenopathy (PGL), and to determine antiviral activity at different doses of DS. Although zidovudine (AZT) has shown promise in prolonging life in patients with AIDS and severe ARC, it has significant blood toxicities. It would be beneficial to combine AZT with another antiviral agent that does not have the same toxicity. DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of DS with AZT has been shown to be more effective than either alone.
NCT00113685 Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 2003-04-01 The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.
NCT00113685 Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury Completed University of Washington N/A 2003-04-01 The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Iron Dextran

Condition Name

Condition Name for Iron Dextran
Intervention Trials
Iron Deficiency Anemia 6
HIV Infections 3
Keratoconus 3
Prostate Cancer Metastatic 2
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Condition MeSH

Condition MeSH for Iron Dextran
Intervention Trials
Anemia, Iron-Deficiency 11
Anemia 6
Wounds and Injuries 4
Diabetes Mellitus 4
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Clinical Trial Locations for Iron Dextran

Trials by Country

Trials by Country for Iron Dextran
Location Trials
United States 68
Canada 6
Sweden 5
Denmark 3
China 2
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Trials by US State

Trials by US State for Iron Dextran
Location Trials
Maryland 9
Pennsylvania 7
California 6
Ohio 4
Alabama 4
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Clinical Trial Progress for Iron Dextran

Clinical Trial Phase

Clinical Trial Phase for Iron Dextran
Clinical Trial Phase Trials
Phase 4 9
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Iron Dextran
Clinical Trial Phase Trials
Completed 25
Terminated 6
Not yet recruiting 6
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Clinical Trial Sponsors for Iron Dextran

Sponsor Name

Sponsor Name for Iron Dextran
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 6
Luitpold Pharmaceuticals 4
Pharmacosmos A/S 3
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Sponsor Type

Sponsor Type for Iron Dextran
Sponsor Trials
Other 46
Industry 22
NIH 17
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