Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
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ClinicalTrials.gov Identifier: NCT01649869 |
Recruitment Status :
Completed
First Posted : July 25, 2012
Results First Posted : June 2, 2021
Last Update Posted : June 2, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Cytomegalovirus Infection |
Interventions |
Other: Placebo Drug: Valganciclovir |
Enrollment | 54 |
Recruitment Details | For this study, subjects were enrolled once they signed the informed consent form (ICF). It was not until after hearing loss was confirmed by audiology testing and confirmation of congenital CMV by dried blood spot that a subject was randomized and started on study drug. This reduced protocol enrollment from 54 to 35. |
Pre-assignment Details |
Arm/Group Title | Placebo | Active |
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27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks |
27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks. |
Period Title: Overall Study | ||
Started | 18 | 17 |
Completed | 16 | 16 |
Not Completed | 2 | 1 |
Reason Not Completed | ||
Family member illness | 1 | 0 |
Required treatment outside protocol | 1 | 0 |
Severe hearing loss borderline eligible | 0 | 1 |
Arm/Group Title | Placebo | Active | Total | |
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27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks |
27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 18 | 17 | 35 | |
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[Not Specified]
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Age, Continuous
Median (Standard Deviation) Unit of measure: MONTHS |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
19.5 (13.1) | 17.8 (15.8) | 18.7 (14.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
Female |
8 44.4%
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6 35.3%
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14 40.0%
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Male |
10 55.6%
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11 64.7%
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21 60.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
17 94.4%
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15 88.2%
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32 91.4%
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Unknown or Not Reported |
1 5.6%
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2 11.8%
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3 8.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 5.6%
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2 11.8%
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3 8.6%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 11.1%
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2 11.8%
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4 11.4%
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White |
15 83.3%
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12 70.6%
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27 77.1%
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More than one race |
0 0.0%
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1 5.9%
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1 2.9%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 18 participants | 17 participants | 35 participants |
United States | 7 | 4 | 11 | |
United Kingdom | 11 | 13 | 24 |
Name/Title: | David Kimberlin, MD |
Organization: | University of Alabama at Birmingham |
Phone: | (205) 638-2530 |
EMail: | DKimberlin@peds.uab.edu |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01649869 |
Other Study ID Numbers: |
11-0069 HHSN272201100035C |
First Submitted: | July 20, 2012 |
First Posted: | July 25, 2012 |
Results First Submitted: | December 23, 2020 |
Results First Posted: | June 2, 2021 |
Last Update Posted: | June 2, 2021 |