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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02370758 |
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Date of registration:
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18/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients
Q-CMV |
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Scientific title:
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Cell Mediated Immunity as a Guide for Secondary Prophylaxis in SOT Patients With CMV Infection |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02370758 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Atul Humar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Name:
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Deepali Kumar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult solid organ transplant (SOT) recipient on at least one immunosuppressive
medication
- Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new
onset CMV disease
- CMV viral load = 1000 IU/mL
Exclusion Criteria:
- Known ganciclovir-resistant CMV
- Known intolerance to valganciclovir or ganciclovir
- Unable to comply with protocol
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cytomegalovirus Viraemia
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Intervention(s)
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Drug: Valganciclovir or Ganciclovir
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Primary Outcome(s)
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Virologic recurrence or disease recurrence
[Time Frame: 6 months]
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Secondary ID(s)
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UHN-CMV-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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