Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00466817 |
Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment. Participants will include 94 infants (30 days old or younger) born with CMV disease. All infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period, subjects will be assigned by chance to receive either valganciclovir or placebo (inactive substance) to complete the 6 months of antiviral treatment.
Patients will be followed for study related endpoints of safety, changes to hearing, and developmental milestones for up to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus, participants may be involved in study related procedures for approximately 5 years.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Infections |
Drug: Placebo Drug: Valganciclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III, Randomized, Placebo-Controlled Blinded Investigation of Six Weeks vs. Six Months of Oral Valganciclovir Therapy in Infants With Symptomatic Congenital Cytomegalovirus Infection (CASG 112) |
Estimated Enrollment: | 94 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator
Subject to receive 6 months of oral placebo.
|
Drug: Placebo
9 g powder which contains no valganciclovir free base.
|
Valganciclovir: Experimental
Subject to receive 6 months of oral Valganciclovir..
|
Drug: Valganciclovir
Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 g powder containing 5 g valganciclovir free base.
|
This study is a multi-center, prospective, international, phase III, randomized and blinded investigation of 6 weeks versus 6 months of oral valganciclovir therapy in babies with symptomatic congenital cytomegalovirus (CMV) disease. Following enrollment, study subjects will receive 6 weeks of oral valganciclovir. Near the end of the 6-week course, subjects will be randomized in a 1:1 fashion either to continue on valganciclovir to complete 6 months of therapy or to begin a matching placebo to complete the 6 months. Study subjects will be stratified according to whether or not there is central nervous system (CNS) involvement at study entry. The total number of enrolled subjects will be 94. During the 6-month treatment period and the 1 month thereafter, study subjects will be followed weekly for 4 weeks, then every other week for 8 weeks, then every month for 4 months. At each of these visits, safety labs will be checked, growth parameters recorded, and adverse events assessed. The dose of study medication will be adjusted for weight gain at each of these study visits. Whole blood will be obtained for CMV viral load at each of these visits as well. Hearing outcomes will be assessed at baseline, 6 months, 12 months, and 24 months. Developmental outcomes will be assessed at 12 months, and 24 months. Changes in whole blood viral load measurements will be correlated with both hearing and neurologic outcomes. In study subjects with increasing whole blood viral loads during the course of treatment, assessment for antiviral resistance may be undertaken. Safety assessments include hematology labs, chemistry labs, physical examinations, and adverse event data performed/collected serially. Development of neutropenia will be confirmed by repeat blood testing within one week, and study drug will be held until it resolves. Efficacy assessments will include hearing assessments at baseline, 6 months, 12 months, and 24 months; and neurodevelopmental assessments at 12 months and 24 months. Study objectives are: to compare the impact on hearing outcomes of 6 weeks versus 6 months of antiviral treatment with valganciclovir oral solution in infants with symptomatic congenital CMV disease; to compare the safety profile of 6 weeks versus 6 months of antiviral therapy with valganciclovir oral solution in infants with symptomatic congenital CMV disease; to compare the impact on neurologic outcomes of 6 weeks versus 6 months of antiviral treatment with valganciclovir oral solution in infants with symptomatic congenital CMV disease; and to correlate change in whole blood viral load with hearing and neurologic outcomes. The primary study endpoint is change in best ear hearing assessments between baseline and 6 months. Secondary study endpoints are: adverse events which lead to permanent discontinuation of valganciclovir therapy or to irreversible outcome of the adverse event; change in best ear hearing assessments between baseline and 12 months; change in best ear hearing assessments between baseline and 24 months; maximum change in hearing assessments between baseline and 6, 12, and 24 months over left and right ears; hearing deterioration between baseline and 6, 12, or 24 months over left and right ears; neurologic impairment at 12 months of life, utilizing the Bayley Scales of Infant and Toddler Development (BSITD); and neurologic impairment at 24 months of life, utilizing the BSITD. Tertiary study endpoints are overall profile of adverse events thought to be related to the study therapy; correlation of change in whole blood viral load with change in hearing between baseline and 12 months of age over left and right ears; correlation of change in whole blood viral load with neurologic impairment at 12 months of life, utilizing the BSITD; and characterization of the population pharmacokinetics of valganciclovir and assessment of adherence during treatment.
Ages Eligible for Study: | up to 30 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptomatic congenital CMV disease, as manifest by one or more of the following:
Exclusion Criteria:
Contact: Richard Whitley | (205) 934-5316 |
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 06-0046, CASG 112 |
Study First Received: | April 26, 2007 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00466817 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration; United States: Federal Government |
Cytomegalovirus, congenital, infants |
Virus Diseases Valganciclovir Congenital Cytomegalovirus Cytomegalic Inclusion Disease Cytomegalovirus Infections |
Ganciclovir DNA Virus Infections Antiviral Agents Cytomegalovirus Herpesviridae Infections |
Virus Diseases Anti-Infective Agents Communicable Diseases Valganciclovir Therapeutic Uses Cytomegalovirus Infections |
Ganciclovir DNA Virus Infections Infection Antiviral Agents Pharmacologic Actions Herpesviridae Infections |