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| Sponsored by: |
University of Wisconsin, Madison |
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00214240 |
Purpose
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
| Condition | Intervention |
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Cytomegalovirus |
Drug: CMV Immune globulin |
| MedlinePlus related topics: | Cytomegalovirus Infections Pancreas Transplantation |
| Drug Information available for: | Immunoglobulins Globulin, Immune Pancrelipase Ultrase CytoGam |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | January 2008 |
| Arms | Assigned Interventions |
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1: Experimental
Cytogam in addition to standard of care (IV ganciclovir therapy)
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Drug: CMV Immune globulin
CMV IvIg 150mg/kg x 6 doses
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2: No Intervention
Receive standard of care therapy (IV ganciclovir)
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |||||
| University of Wisconsin | |||||
| Madison, Wisconsin, United States, 53792 | |||||
| University of Wisconsin, Madison |
| Principal Investigator: | John Pirsch, MD | University of Wisconsin, Madison |
More Information
| Responsible Party: | University of Wisconsin ( John Pirsch, MD ) |
| Study ID Numbers: | 1999-492 |
| First Received: | September 13, 2005 |
| Last Updated: | December 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00214240 |
| Health Authority: | United States: Food and Drug Administration |
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