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| Tracking Information | |||||
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| First Received Date ICMJE | August 8, 2006 | ||||
| Last Updated Date | June 16, 2009 | ||||
| Start Date ICMJE | December 2008 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00361933 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease | ||||
| Official Title ICMJE | Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir | ||||
| Brief Summary | The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA approved for treating a different type of Human Herpesvirus, but not approved for the treatment of HHV-8. It is therefore considered experimental in this study. |
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| Detailed Description | All participants will undergo an initial screening appointment. At this visit, participants will be tested for Human Herpesvirus 8 (HHV-8), the virus that is associated with MCD, and we will review participants' medical history and medical records to determine whether he/she has MCD. If participants do not live within the Seattle area, this visit may occur over the phone. Those who qualify for the study will be followed for up to 2 years. During that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. If subjects do not live within the Seattle-area, they will be asked to ship these samples to UW for testing. We will provide subjects with instructions for these shipments. This will be done at no cost to the participant. If during the 2 year period the participant experiences a MCD flare, he/she will be admitted to the University of Washington Medical Center's Clinic Research Center for 14-days. If the participant does not live within the Seattle-area, all travel expenses will be covered. The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. Everyday during the hospitalization, participants will have blood drawn (to check your HHV-8 levels), 1 oral swab will be collected and a general physical exam will be performed. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase IV | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Giant Lymph Node Hyperplasia | ||||
| Intervention ICMJE | Drug: Valganciclovir
valganciclovir open label, two 450mg tablets orally, twice a day
Other Name: Valcyte |
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| Study Arms | Experimental: 1
Intervention: Drug: Valganciclovir |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 8 | ||||
| Estimated Completion Date | May 2009 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00361933 | ||||
| Other Study ID Numbers ICMJE | 30618-A, VAL096 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Corey Casper, MD, MPH, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | Hoffmann-La Roche | ||||
| Investigators ICMJE |
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| Information Provided By | University of Washington | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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