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| ID | Type | Description | Link |
|---|---|---|---|
| CASG 112 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valganciclovir | Experimental | Six months of oral Valganciclovir. |
|
| Placebo | Placebo Comparator | Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Ear Hearing Assessments at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | 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 |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Children's of Alabama - Clinical Virology | Birmingham | Alabama | 35233-1711 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25738669 | Derived | Kimberlin DW, Jester PM, Sanchez PJ, Ahmed A, Arav-Boger R, Michaels MG, Ashouri N, Englund JA, Estrada B, Jacobs RF, Romero JR, Sood SK, Whitworth MS, Abzug MJ, Caserta MT, Fowler S, Lujan-Zilbermann J, Storch GA, DeBiasi RL, Han JY, Palmer A, Weiner LB, Bocchini JA, Dennehy PH, Finn A, Griffiths PD, Luck S, Gutierrez K, Halasa N, Homans J, Shane AL, Sharland M, Simonsen K, Vanchiere JA, Woods CR, Sabo DL, Aban I, Kuo H, James SH, Prichard MN, Griffin J, Giles D, Acosta EP, Whitley RJ; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Valganciclovir for symptomatic congenital cytomegalovirus disease. N Engl J Med. 2015 Mar 5;372(10):933-43. doi: 10.1056/NEJMoa1404599. |
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All 109 subjects started on valganciclovir. At the end of 6 weeks, subjects were randomized to valganciclovir or placebo. of the 109 subject that started, 12 dropped out before randomization and 1 subject was randomized but never received any blinded study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo | Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Valganciclovir | Drug | 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. |
|
| Change in Best Ear Hearing Assessments at 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. | 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) | 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) | 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) | 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) | 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) | 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) | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 24 Months after enrollment. |
| Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score). | 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. | 24 Months after enrollment |
| University of South Alabama - Children's Specialty Clinic |
| Mobile |
| Alabama |
| 36604-3207 |
| United States |
| Arkansas Children's Hospital - Infectious Diseases | Little Rock | Arkansas | 72202-3500 | United States |
| Los Angeles County - University of Southern California - Medical Center - Pediatrics | Los Angeles | California | 90033-1075 | United States |
| Plaza Towers Obstetrics and Gynecology | Los Angeles | California | 90048-5970 | United States |
| Children's Hospital of Orange County - Infectious Diseases | Orange | California | 92868-3835 | United States |
| Stanford University School of Medicine | Stanford | California | 94305-2200 | United States |
| Children's Hospital Colorado - Infectious Disease | Aurora | Colorado | 80045-7106 | United States |
| Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease | Washington D.C. | District of Columbia | 20010-2916 | United States |
| University of Florida - College of Medicine - Jacksonville | Jacksonville | Florida | 32209-6511 | United States |
| University of South Florida - Tampa General Hospital - Pediatrics | Tampa | Florida | 33606-3438 | United States |
| Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia | 30322-1014 | United States |
| University of Louisville School of Medicine - Kosair Childrens Hospital - Infectious Diseases | Louisville | Kentucky | 40202-1821 | United States |
| Tulane University - Tulane Medical Center - Pediatrics | New Orleans | Louisiana | 70112-2600 | United States |
| Louisiana State University Health Shreveport - Pediatrics | Shreveport | Louisiana | 71103-4228 | United States |
| Johns Hopkins Children's Center - Pediatric Infectious Diseases | Baltimore | Maryland | 21287-0011 | United States |
| Children's Hospital Boston - Infectious Diseases | Boston | Massachusetts | 02115-5711 | United States |
| University of Minnesota - Pediatric Infectious Disease | Minneapolis | Minnesota | 55455-0341 | United States |
| University of Mississippi - Children's Infectious Diseases | Jackson | Mississippi | 39216-4505 | United States |
| Children's Mercy Hospital and Clinics - Infectious Diseases | Kansas City | Missouri | 64108-4619 | United States |
| Washington University School of Medicine in St. Louis - Center for Clinical Studies | St Louis | Missouri | 63110-1010 | United States |
| Creighton University Medical Center - Medicine - Infectious Diseases | Omaha | Nebraska | 68131-2137 | United States |
| Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases | New Brunswick | New Jersey | 08901-1766 | United States |
| Robert Wood Johnson Medical School - Pediatrics | New Brunswick | New Jersey | 08901-1935 | United States |
| Women & Children's Hospital of Buffalo - Infectious Diseases | Buffalo | New York | 14222-2006 | United States |
| Cohen Children's Medical Center - Pediatric Infectious Diseases | Manhasset | New York | 11030-3816 | United States |
| University of Rochester Medical Center - Golisano Children's Hospital - Infectious Diseases | Rochester | New York | 14642-0001 | United States |
| SUNY Upstate Medical University Hospital - Pediatrics | Syracuse | New York | 13210-2342 | United States |
| Carolinas Medical Center - Pediatrics - Infectious Diseases | Charlotte | North Carolina | 28203-5812 | United States |
| MetroHealth Medical Center - Pediatric Infectious Disease | Cleveland | Ohio | 44109-1998 | United States |
| Cleveland Clinic Main Campus - Center for Pediatric Infectious Diseases | Cleveland | Ohio | 44195-0001 | United States |
| Nationwide Children's Hospital - Infectious Diseases | Columbus | Ohio | 43205-2664 | United States |
| Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases | Pittsburgh | Pennsylvania | 15224-1529 | United States |
| Rhode Island Hospital - Pediatrics | Providence | Rhode Island | 02903-4923 | United States |
| Medical University of South Carolina - Pediatrics - Infectious Diseases | Charleston | South Carolina | 29425-8903 | United States |
| Vanderbilt University - Pediatric - Infectious Diseases | Nashville | Tennessee | 37232-0011 | United States |
| Children's Medical Center Dallas - Neonatal ICU | Dallas | Texas | 75235-7701 | United States |
| University of Texas Southwestern Medical Center - Pediatrics | Dallas | Texas | 75390-9063 | United States |
| Cook Children's Infectious Disease Services | Fort Worth | Texas | 76104-2710 | United States |
| University of Utah - Pediatric Pharmacology Program | Salt Lake City | Utah | 84108-1457 | United States |
| Seattle Children's Hospital - Infectious Diseases | Seattle | Washington | 98105-3901 | United States |
| Birmingham Heartlands Hospital | Birmingham | Birmingham | B9 5SS | United Kingdom |
| Bristol Royal Hospital for Children - UBHT Education Centre | Bristol | Bristol, City of | BS2 8AE | United Kingdom |
| Alder Hey Childrens Hospital | Liverpool | Liverpool | L12 2AP | United Kingdom |
| University College London - Royal Free Campus - Virology | London | London, City of | NW3 2PF | United Kingdom |
| Saint George's Hospital - Pediatric Infectious Diseases | London | London, City of | SW17 0QT | United Kingdom |
| Newcastle General Hospital | Newcastle upon Tyne | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| FG001 | Valganciclovir: 24 Wks of Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo | Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period. Placebo : 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. |
| BG001 | Valganciclovir: 24 Wks of Valganciclovir | Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir. Valganciclovir : 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Change in Best Ear Hearing Assessments at 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. | Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported | Posted | Number | participants | Between baseline and 6 months |
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| Secondary | Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | 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. | Posted | Number | participants | baseline through 7 months |
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| Secondary | Change in Best Ear Hearing Assessments at 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. | Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods | Posted | Number | participants | Between baseline and 12 months |
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| Secondary | Change in Best Ear Hearing Assessments at 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. | Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods | Posted | Number | participants | Between baseline and 24 months |
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| Secondary | 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) | 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. | Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported | Posted | Number | ears | Between baseline and 6 months |
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| Secondary | 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) | 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. | Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed. | Posted | Number | ears | Between baseline and 12 months |
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| Secondary | 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) | 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. | Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods. | Posted | Number | ears | Between baseline and 24 months |
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| Secondary | 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) | 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. | Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported | Posted | Number | ears | Between baseline and 6 months |
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| Secondary | 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) | 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. | Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods | Posted | Number | ears | Between baseline and 12 months |
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| Secondary | 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) | 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. | Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods. | Posted | Number | ears | Between baseline and 24 months |
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| Secondary | Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score). | 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. | only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed | Posted | Mean | Standard Error | units on a scale | 12 Months after enrollment |
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| Secondary | Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed | Posted | Mean | Standard Error | units on a scale | 24 Months after enrollment |
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| Secondary | Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed | Posted | Mean | Standard Error | units on a scale | 24 months after enrollment |
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| Secondary | Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed | Posted | Mean | Standard Error | units on a scale | 24 Months after enrollment |
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| Secondary | Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed | Posted | Mean | Standard Error | units on a scale | 24 Months after enrollment |
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| Secondary | Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed | Posted | Mean | Standard Error | units on a scale | 24 Months after enrollment |
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| Secondary | Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed | Posted | Mean | Standard Error | units on a scale | 24 Months after enrollment. |
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| Secondary | Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score). | 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. | only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed | Posted | Mean | Standard Error | units on a scale | 24 Months after enrollment |
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Adverse events were reported between baseline and 7 months
There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non Randomized | 6 weeks of open label valganciclovir only | 1 | 13 | 3 | 13 | ||
| EG001 | Active | 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir | 11 | 47 | 45 | 47 | ||
| EG002 | Placebo After 6 Weeks of Valganciclovir | 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo | 19 | 49 | 47 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Vomoting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Otitis medial | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Feeding disorder neonatal | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neutropenia Neonatal | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Red blood cell abnormality | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Splenomegaly | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| White blood cell disorder | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cyanosis | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Middle ear effusion | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Otorrhoea | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Astigmatism | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Conjunctival irritation | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eye movement disorder | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lacrimal disorder | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Photalgia | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Strabismus | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Swollen tear duct | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Infantile colic | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Infantile spitting up | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Reflux gastritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fever neonatal | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Irritability postvaccinal | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Otitis media bacterial | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Recurring skin boils | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Feeding tube complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bacteria stool identified | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemoglobin abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Head lag | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neutrophil count abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nuclear magnetic resonance imaging abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Stool analysis abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fluid intake reduced | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Head deformity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ligament laxity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Crying | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Infantile spasms | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Reflexes abnormal | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sleep phase rhythm disturbance | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Genital erythema | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Allergic respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasopharyngeal reflux | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acne infantile | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Erythema toxicum neonatorum | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Circumcision | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oxygen supplementation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kimberlin, MD | University of Alabama in Birmingham | 205-934-2424 | dkimberlin@peds.uab.edu |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| One point improvement |
|
| Counts |
|---|
| Participants |
|
|
| OG001 | Valganciclovir: 24 Weeks of Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir: 24 Wks of Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir: 24 Wks of Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir: 24 Wks of Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir: 24 Wks of Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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. |
|
|
| OG001 | Valganciclovir | Six months of oral Valganciclovir. Valganciclovir : 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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