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| Sponsor: | University of Minnesota - Clinical and Translational Science Institute |
|---|---|
| Collaborator: |
Epiphany Biosciences |
| Information provided by: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00575185 |
Purpose
This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical diagnosis of primary infectious mononucleosis will be screened and those with laboratory-confirmed primary EBV infection will be enrolled.
| Condition | Intervention | Phase |
|---|---|---|
|
Infectious Mononucleosis |
Drug: Valomaciclovir Drug: placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Placebo-Controlled, Double-Blind Study to Assess Clinical and Antiviral Activity of Valomaciclovir (EPB 348) in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono 6) |
| Enrollment: | 23 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Valomaciclovir
4 grams orally of valomaciclovir (2 grams BID) for 21 days.
|
| Placebo Comparator: 2 |
Drug: placebo
Placebo tablets orally twice daily for 21 days.
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Henry H Balfour, MD | Professor of Laboratory Medicine & Pathology, and Pediatrics |
More Information
| Responsible Party: | Henry H. Balfour, Jr., University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00575185 History of Changes |
| Other Study ID Numbers: | 0709M16341 |
| Study First Received: | December 14, 2007 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Mono Mononucleosis Epstein-Barr virus |
|
Communicable Diseases Infection Infectious Mononucleosis Virus Diseases Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Leukocyte Disorders |
Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Tumor Virus Infections Neoplasms, Experimental Neoplasms |