- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466817
Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
August 13, 2015 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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)
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 104 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 the study related evaluations 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Dose adjustments may also occur as indicated per protocol for neutropenia, thrombocytopenia, or renal impairment.
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 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.
Participants will include 104 male and female neonates (less than or equal to 30 days) with symptomatic congenital CMV.
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Birmingham, United Kingdom, B9 5SS
- Birmingham Heartlands Hospital
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Liverpool, United Kingdom, L12 2AP
- Alder Hey Childrens Hospital
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Newcastle Upon Tyne, United Kingdom, NE4 6BE
- Newcastle General Hospital
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Bristol, City of
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Bristol, Bristol, City of, United Kingdom, BS2 8AE
- Bristol Royal Hospital for Children - UBHT Education Centre
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London, City of
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London, London, City of, United Kingdom, NW3 2PF
- University College London - Royal Free Campus - Virology
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London, London, City of, United Kingdom, SW17 0QT
- Saint George's Hospital - Pediatric Infectious Diseases
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- John Radcliffe Hospital
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Alabama
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Birmingham, Alabama, United States, 35233-1711
- University of Alabama - Children's of Alabama - Clinical Virology
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Mobile, Alabama, United States, 36604-3207
- University of South Alabama - Children's Specialty Clinic
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Arkansas
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Little Rock, Arkansas, United States, 72202-3500
- Arkansas Children's Hospital - Infectious Diseases
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California
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Los Angeles, California, United States, 90033-1075
- Los Angeles County - University of Southern California - Medical Center - Pediatrics
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Los Angeles, California, United States, 90048-5970
- Plaza Towers Obstetrics and Gynecology
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Orange, California, United States, 92868-3835
- Children's Hospital of Orange County - Infectious Diseases
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Stanford, California, United States, 94305-2200
- Stanford University School of Medicine
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Colorado
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Aurora, Colorado, United States, 80045-7106
- Children's Hospital Colorado - Infectious Disease
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District of Columbia
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Washington, District of Columbia, United States, 20010-2916
- Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease
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Florida
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Jacksonville, Florida, United States, 32209-6511
- University of Florida - College of Medicine - Jacksonville
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Tampa, Florida, United States, 33606-3438
- University of South Florida - Tampa General Hospital - Pediatrics
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Georgia
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Atlanta, Georgia, United States, 30322-1014
- Emory Children's Center - Pediatric Infectious Diseases
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Kentucky
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Louisville, Kentucky, United States, 40202-1821
- University of Louisville School of Medicine - Kosair Childrens Hospital - Infectious Diseases
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Louisiana
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New Orleans, Louisiana, United States, 70112-2600
- Tulane University - Tulane Medical Center - Pediatrics
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Shreveport, Louisiana, United States, 71103-4228
- Louisiana State University Health Shreveport - Pediatrics
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Maryland
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Baltimore, Maryland, United States, 21287-0011
- Johns Hopkins Children's Center - Pediatric Infectious Diseases
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Massachusetts
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Boston, Massachusetts, United States, 02115-5711
- Children's Hospital Boston - Infectious Diseases
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Minnesota
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Minneapolis, Minnesota, United States, 55455-0341
- University of Minnesota - Pediatric Infectious Disease
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi - Children's Infectious Diseases
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Missouri
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Kansas City, Missouri, United States, 64108-4619
- Children's Mercy Hospital and Clinics - Infectious Diseases
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Saint Louis, Missouri, United States, 63110-1010
- Washington University School of Medicine in St. Louis - Center for Clinical Studies
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Nebraska
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Omaha, Nebraska, United States, 68131-2137
- Creighton University Medical Center - Medicine - Infectious Diseases
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New Jersey
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New Brunswick, New Jersey, United States, 08901-1766
- Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases
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New Brunswick, New Jersey, United States, 08901-1935
- Robert Wood Johnson Medical School - Pediatrics
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New York
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Buffalo, New York, United States, 14222-2006
- Women & Children's Hospital of Buffalo - Infectious Diseases
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Manhasset, New York, United States, 11030-3816
- Cohen Children's Medical Center - Pediatric Infectious Diseases
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Rochester, New York, United States, 14642-0001
- University of Rochester Medical Center - Golisano Children's Hospital - Infectious Diseases
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Syracuse, New York, United States, 13210-2342
- SUNY Upstate Medical University Hospital - Pediatrics
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North Carolina
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Charlotte, North Carolina, United States, 28203-5812
- Carolinas Medical Center - Pediatrics - Infectious Diseases
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Ohio
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Cleveland, Ohio, United States, 44109-1998
- MetroHealth Medical Center - Pediatric Infectious Disease
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Cleveland, Ohio, United States, 44195-0001
- Cleveland Clinic Main Campus - Center for Pediatric Infectious Diseases
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Columbus, Ohio, United States, 43205-2664
- Nationwide Children's Hospital - Infectious Diseases
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224-1529
- Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases
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Rhode Island
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Providence, Rhode Island, United States, 02903-4923
- Rhode Island Hospital - Pediatrics
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South Carolina
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Charleston, South Carolina, United States, 29425-8903
- Medical University of South Carolina - Pediatrics - Infectious Diseases
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Tennessee
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Nashville, Tennessee, United States, 37232-0011
- Vanderbilt University - Pediatric - Infectious Diseases
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Texas
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Dallas, Texas, United States, 75235-7701
- Children's Medical Center Dallas - Neonatal ICU
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Dallas, Texas, United States, 75390-9063
- University of Texas Southwestern Medical Center - Pediatrics
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Fort Worth, Texas, United States, 76104-2710
- Cook Children's Infectious Disease Services
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Utah
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Salt Lake City, Utah, United States, 84108-1457
- University of Utah - Pediatric Pharmacology Program
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Washington
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Seattle, Washington, United States, 98105-3901
- Seattle Children's Hospital - Infectious Diseases
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent from parent(s) or legal guardian(s)
- Confirmation of cytomegalovirus (CMV) from urine or throat swab specimens by culture, shell vial, or polymerase chain reaction (PCR) tests
Symptomatic congenital CMV disease, as manifest by one or more of the following:
- Thrombocytopenia
- Petechiae
- Hepatomegaly
- Splenomegaly
- Intrauterine growth restriction
- Hepatitis (elevated transaminases and/or bilirubin)
- Central nervous system (CNS) involvement of the CMV disease [such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal cerebrospinal fluid (CSF) indices for age, chorioretinitis, hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response {ABR}), and/or positive CMV PCR from CSF]
- Less than or equal to 30 days of age at study enrollment
- Weight at study enrollment greater than or equal to 1800 grams
- Gestational age greater than or equal to 32 weeks at birth
Exclusion Criteria:
- Imminent demise
- Patients receiving other antiviral agents or immune globulin
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
- Documented renal insufficiency, as noted by a creatinine clearance less than 10 mL/min/1.73m^2 at time of study enrollment
- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribivir
- Infants known to be born to women who are human immunodeficiency virus (HIV) positive (but HIV testing is not required for study entry)
- Current receipt of other investigational drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Valganciclovir
Six months of oral Valganciclovir.
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Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base.
The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
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Placebo Comparator: Placebo
Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
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9 grams of powder which contains no Valganciclovir free base.
The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Best Ear Hearing Assessments at 6 Months.
Time Frame: Between baseline and 6 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
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Between baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.
Time Frame: baseline through 7 months
|
Adverse events were assessed at each visit through month 7 of the study.
No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.
|
baseline through 7 months
|
Change in Best Ear Hearing Assessments at 12 Months.
Time Frame: Between baseline and 12 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 12 months
|
Change in Best Ear Hearing Assessments at 24 Months.
Time Frame: Between baseline and 24 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 24 months
|
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)
Time Frame: Between baseline and 6 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 6 months
|
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)
Time Frame: Between baseline and 12 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 12 months
|
Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)
Time Frame: Between baseline and 24 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 24 months
|
Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)
Time Frame: Between baseline and 6 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 6 months
|
Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)
Time Frame: Between baseline and 12 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 12 months
|
Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)
Time Frame: Between baseline and 24 months
|
Hearing assessment was evaluated by an independent audiologist.
At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained.
At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained.
A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels).
The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications.
Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
|
Between baseline and 24 months
|
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).
Time Frame: 12 Months after enrollment
|
Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.
|
12 Months after enrollment
|
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Time Frame: 12 Months after enrollment
|
Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
12 Months after enrollment
|
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Time Frame: 12 Months after enrollment
|
Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
12 Months after enrollment
|
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Time Frame: 12 Months after enrollment
|
Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.
|
12 Months after enrollment
|
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Time Frame: 12 Months after enrollment
|
Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
12 Months after enrollment
|
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Time Frame: 12 Months after enrollment
|
Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
12 Months after enrollment
|
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Time Frame: 12 Months after enrollment
|
Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.
|
12 Months after enrollment
|
Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Time Frame: 24 Months after enrollment
|
Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
24 Months after enrollment
|
Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).
Time Frame: 24 months after enrollment
|
Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.
|
24 months after enrollment
|
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Time Frame: 24 Months after enrollment
|
Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
24 Months after enrollment
|
Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Time Frame: 24 Months after enrollment
|
Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.
|
24 Months after enrollment
|
Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Time Frame: 24 Months after enrollment
|
Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
|
24 Months after enrollment
|
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Time Frame: 24 Months after enrollment.
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Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
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24 Months after enrollment.
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Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Time Frame: 24 Months after enrollment
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Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development.
For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.
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24 Months after enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
April 26, 2007
First Submitted That Met QC Criteria
April 26, 2007
First Posted (Estimate)
April 27, 2007
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 13, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0046
- CASG 112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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