Cytomegalovirus InfectionPhase 2NCT01649869
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
A Phase 2 study testing Valganciclovir in people with Cytomegalovirus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in 2 countries.
Trial summary
This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 24 Feb 2015to 24 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent from parent(s) or legal guardian(s)
- Sensorineural hearing loss (>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)
- Children from 1 month through 3 years of age (up to the 4th birthday)
Who cannot join
- Imminent demise
- Profound sensorineural hearing loss (> 90dB) in both ears
- Patients receiving other antiviral agents or immune globulin
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
- Documented renal insufficiency, as noted by a creatinine clearance < 10 mL/min/1.73m2 at time of study enrollment
- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribavir
Show all 14Show fewer
- Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
- Current receipt of other investigational drugs
- Previous receipt of ganciclovir or valganciclovir
- Known hypersensitivity to ganciclovir, valganciclovir, or components of the product
- Inability to attend follow-up hearing and clinical assessments
- Infants with Auditory neuropathy/dyssynchrony.
- Children with another known etiology for SNHL (e.g. connexin 26, syndrome or metabolic disorder associated with SNHL, inner ear malformation and widened vestibular aqueducts, meningitis).
- Exclusion of each of these conditions is not required for trial enrollment.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States9 sites
Children's of Alabama Child Health Research Unit (CHRU)
Birmingham, Alabama, 35233-0011
Carolinas Medical Center - Pediatrics - Infectious Diseases
Charlotte, North Carolina, 28203-5812
Nationwide Children's Hospital - Neonatology - Center for Perinatal Research
Columbus, Ohio, 43205-2664
Texas Medical Center - Texas Children's Hospital
Houston, Texas, 77030
Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease
Manhasset, New York, 11030-3816
Rhode Island Hospital - Pediatrics
Providence, Rhode Island, 02903-4923
University of Rochester Medical Center
Rochester, New York, 14642-0001
Washington University School of Medicine in St. Louis - Center for Clinical Studies
St Louis, Missouri, 63110-1010
Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease
Washington D.C., District of Columbia, 20010-2916
United Kingdom9 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Bristol Royal Hospital for Children - Paediatric Immunology
Bristol, Bristol, City of, BS2 8BJ
Pennine Acute Hospitals NHS Trust, North Manchester General Hospital - Children's and Adolescent Services
Crumpsall, M8 5RB
John Radcliffe Hospital - Children's Hospital - Paediatric Infectious Disease and Immunology
Headington, Oxford, OX3 9DU
Saint George's Hospital - Pediatric Infectious Diseases
London, London, City of, SW17 0QT
Great Ormond Street Hospital - Infectious Diseases
London, London, City of, WC1N 3JH
The Great North Children's Hospital - Paediatric Immunology
Newcastle upon Tyne, NE14LP
Sheffield Children's Hospital - Immunology
Sheffield, S10 2TH
Southampton Children's Hospital - Allergy, Immunology and Infection
Southampton, Hampshire, SO16 6YD
About this study
Official title: A Phase II Randomized and Controlled Investigation of Six Weeks of Oral Valganciclovir Therapy in Infants and Children With Congenital Cytomegalovirus Infection and Hearing Loss
This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.
Read the detailed description
Congenital cytomegalovirus (CMV) infection is the most frequent known viral cause of mental retardation, and is the leading non-genetic cause of sensorineural hearing loss in many countries including the United States. This is a Phase II international, multi-center, double-blind, placebo-controlled evaluation of 6 weeks of oral valganciclovir treatment or 6 weeks of placebo for fifty-four male and female infants/toddlers 1 month through 3 years of age (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Patient who are between 1 month and 4 years of age and who have SNHL (Sensorineural Hearing Loss) and are eligible for enrollment. The expected study duration is 3.5 years from enrollment of first study subject. The primary objective is to assess whether a six week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss. The secondary objective is to define the following responses as a function of systemic exposure to ganciclovir (active metabolite of valganciclovir): CMV viral load in blood; CMV viral load in urine; and CMV viral load in saliva. Also, to define the safety and tolerability of valganciclovir in enrolled subjects. The tertiary objective is to define the pharmacokinetics of ganciclovir (metabolite) following administration of valganciclovir (prodrug) in enrolled subjects.
- Conditions
- Cytomegalovirus Infection
- Being tested
- Placebo, Valganciclovir
- Keywords
- CMV, Cytomegalovirus, Hearing Loss, Infants, Valganciclovir
- Medical subject headings
- Cytomegalovirus Infections, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks
ValganciclovirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 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 Receives: Drug: Valganciclovir |
| Placebo | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss. Not both ears are evaluable for all subjects. In some subjects, only one ear is evaluable.
Measured: Day 1 through Day 180
Secondary outcomes (25)
Number of Best Ear That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing [ex. Improved+ no Change (Normal to Normal) Versus Other].
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss. For this outcome, we combine the improved hearing and no change for the special case only of normal to normal. Other category include worsened and no change from (1) mild to mild hearing loss, (2) moderate to moderate hearing loss, or (3) severe to severe hearing loss.
Measured: Day 1 through Day 180
Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss.
Measured: Day 1 through Day 180
Change in Best Ear Hearing Assessments [Worse + no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss.
Measured: Day 1 through Day 180
Change in Best Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss.
Measured: Day 1 through Day 180
Change in Total Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss.
Measured: Day 1 through Day 180
Change in Total Ear Hearing Assessments [Worse+ no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss.
Measured: Day 1 through Day 180
Change in Total Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss.
Measured: Day 1 through Day 180
Association of Change in Viral Load (Blood) With Change in Total Ear Hearing at 6 Months
Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Measured: At 6 months
Association of Change in Viral Load (Saliva) With Change in Total Ear Hearing at 6 Months
Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units or log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Measured: At 6 months
Association of Change in Viral Load (Urine) With Change in Total Ear Hearing at 6 Months
Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Measured: At 6 months
Association of Change in Viral Load (Blood) With Change in Best Ear Hearing at 6 Months
Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Measured: At 6 months
Association of Change in Viral Load (Saliva) With Change in Best Ear Hearing at 6 Months
Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Measured: At 6 months
Association of Change in Viral Load (Urine) With Change in Best Ear Hearing at 6 Months
Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Measured: At 6 months
Detection of Viruria (Urine) by PCR Six Weeks After Trial Entry
Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Measured: At 6 weeks (Day 42)
Detection of Viruria (Urine) by PCR Six Month After Trial Entry
Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Measured: At 6 months
Detection of Viremia (Blood) by PCR Six Weeks After Trial Entry
Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Measured: At 6 weeks (Day 42)
Detection of Viremia (Blood) by PCR Six Month After Trial Entry
Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Measured: At 6 months
Detection of CMV in Saliva by PCR Six Weeks After Trial Entry
Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Measured: At 6 weeks (Day 42)
Detection of CMV in Saliva PCR Six Month After Trial Entry
Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Measured: At 6 months
The Quantitative Log Change in Viremia From Baseline to Month 6.
The quantitative change (Month 6 minus baseline) in viremia (blood) Quantitative viral load by PCR in log 10 units measured in urine after 6 weeks of therapy; if undetectable, viral load is assigned a value of 10 (1 in log 10 units).
Measured: Baseline to month 6
The Quantitative Log Reduction in Viruria Detected After 6 Weeks of Therapy
The quantitative log reduction in viruria (urine) detected after 6 weeks of therapy. Quantitative viral load by PCR in log 10 units measured in urine after 6 weeks of therapy; if undetectable, viral load is assigned a value of 10 (1 in log 10 units)
Measured: Baseline thru months 6
The Quantitative Log Reduction in CMV in Saliva Detected After 6 Weeks of Therapy
The quantitative log reduction in CMV in saliva (urine) detected after 6 weeks of therapy. Quantitative viral load by PCR in log 10 units measured in urine after 6 weeks of therapy; if undetectable, viral load is assigned a value of 10 (1 in log 10 units)
Measured: Baseline thru months 6
Number of Adverse Events in the Active Group That Resulted in Discontinuation of Valganciclovir
AE resulting in discontinuation of valganciclovir (active group only). This outcome summarizes the number of adverse events (AEs) that resulted in the discontinuation of valganciclovir in the active group only.
Measured: Day 1 thru day 70
Adverse Event (AE) Resulting in Unresolved Outcome
Adverse event resulting in unresolved outcome. This outcome summarizes the number of adverse events (AEs) that resulted in unresolved outcome of that AE.
Measured: Day 1 thru day 70
Adverse Event (AE) Resulting in Unanticipated Medically Attended Visit
Adverse event resulting in unanticipated medically attended visit. This outcome summarizes the number of adverse events (AEs) that resulted in the unanticipated medically attended visit.
Measured: Day 1 thru day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study start24 Feb 2015
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649869
- Sponsor's protocol ID
- 11-0069
- Status last verified
- 22 Mar 2018
- First submitted
- 20 Jul 2012
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kimberlin DW, Aban I, Peri K, Nishikawa JK, Bernatoniene J, Emonts M, Klein N, Bamford A, DeBiasi RL, Faust SN, Jones CE, McMaster P, Caserta M, Ahmed A, Sharland M, Demmler-Harrison G, Hackett S, Sanchez PJ, Shackley F, Kelly D, Dennehy PH, Storch GA, Whitley RJ, Griffiths P; Collaborative Antiviral Study Group (CASG). Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial. J Pediatr. 2024 May;268:113934. doi: 10.1016/j.jpeds.2024.113934. Epub 2024 Feb 2.
PubMed 38309519
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized and Controlled Investigation of Six Weeks of Oral Valganciclovir Therapy in Infants and Children With Congenital Cytomegalovirus Infection and Hearing Loss
- ClinicalTrials.gov ID
- NCT01649869
- Acronym / sponsor ID
- 11-0069
- Conditions
- Cytomegalovirus Infection
- Keywords
- CMV, Cytomegalovirus, Hearing Loss, Infants, Valganciclovir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Posted 2 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.
Detailed description
Congenital cytomegalovirus (CMV) infection is the most frequent known viral cause of mental retardation, and is the leading non-genetic cause of sensorineural hearing loss in many countries including the United States. This is a Phase II international, multi-center, double-blind, placebo-controlled evaluation of 6 weeks of oral valganciclovir treatment or 6 weeks of placebo for fifty-four male and female infants/toddlers 1 month through 3 years of age (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Patient who are between 1 month and 4 years of age and who have SNHL (Sensorineural Hearing Loss) and are eligible for enrollment. The expected study duration is 3.5 years from enrollment of first study subject. The primary objective is to assess whether a six week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss. The secondary objective is to define the following responses as a function of systemic exposure to ganciclovir (active metabolite of valganciclovir): CMV viral load in blood; CMV viral load in urine; and CMV viral load in saliva. Also, to define the safety and tolerability of valganciclovir in enrolled subjects. The tertiary objective is to define the pharmacokinetics of ganciclovir (metabolite) following administration of valganciclovir (prodrug) in enrolled subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Valganciclovir27 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 |
| Placebo | Placebo comparator | Other: Placebo27 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 |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Signed informed consent from parent(s) or legal guardian(s)
- Sensorineural hearing loss (>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)
- Children from 1 month through 3 years of age (up to the 4th birthday)
Key exclusion criteria (14 listed)
- Imminent demise
- Profound sensorineural hearing loss (> 90dB) in both ears
- Patients receiving other antiviral agents or immune globulin
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
- Documented renal insufficiency, as noted by a creatinine clearance < 10 mL/min/1.73m2 at time of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSimple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks | Other | Placebo |
| ValganciclovirValcyte (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. | Drug | Active |
Primary outcome
Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing.
Time frame: Day 1 through Day 180
A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; 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 will be mild hearing loss. Not both ears are evaluable for all subjects. In some subjects, only one ear is evaluable.
25 secondary outcomes
Number of Best Ear That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing [ex. Improved+ no Change (Normal to Normal) Versus Other].
Time frame: Day 1 through Day 180
Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.
Time frame: Day 1 through Day 180
Change in Best Ear Hearing Assessments [Worse + no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.
Time frame: Day 1 through Day 180
Change in Best Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.
Time frame: Day 1 through Day 180
Change in Total Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.
Time frame: Day 1 through Day 180
Change in Total Ear Hearing Assessments [Worse+ no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.
Time frame: Day 1 through Day 180
Change in Total Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.
Time frame: Day 1 through Day 180
Association of Change in Viral Load (Blood) With Change in Total Ear Hearing at 6 Months
Time frame: At 6 months
Association of Change in Viral Load (Saliva) With Change in Total Ear Hearing at 6 Months
Time frame: At 6 months
Association of Change in Viral Load (Urine) With Change in Total Ear Hearing at 6 Months
Time frame: At 6 months
Association of Change in Viral Load (Blood) With Change in Best Ear Hearing at 6 Months
Time frame: At 6 months
Association of Change in Viral Load (Saliva) With Change in Best Ear Hearing at 6 Months
Time frame: At 6 months
Association of Change in Viral Load (Urine) With Change in Best Ear Hearing at 6 Months
Time frame: At 6 months
Detection of Viruria (Urine) by PCR Six Weeks After Trial Entry
Time frame: At 6 weeks (Day 42)
Detection of Viruria (Urine) by PCR Six Month After Trial Entry
Time frame: At 6 months
Detection of Viremia (Blood) by PCR Six Weeks After Trial Entry
Time frame: At 6 weeks (Day 42)
Detection of Viremia (Blood) by PCR Six Month After Trial Entry
Time frame: At 6 months
Detection of CMV in Saliva by PCR Six Weeks After Trial Entry
Time frame: At 6 weeks (Day 42)
Detection of CMV in Saliva PCR Six Month After Trial Entry
Time frame: At 6 months
The Quantitative Log Change in Viremia From Baseline to Month 6.
Time frame: Baseline to month 6
The Quantitative Log Reduction in Viruria Detected After 6 Weeks of Therapy
Time frame: Baseline thru months 6
The Quantitative Log Reduction in CMV in Saliva Detected After 6 Weeks of Therapy
Time frame: Baseline thru months 6
Number of Adverse Events in the Active Group That Resulted in Discontinuation of Valganciclovir
Time frame: Day 1 thru day 70
Adverse Event (AE) Resulting in Unresolved Outcome
Time frame: Day 1 thru day 70
Adverse Event (AE) Resulting in Unanticipated Medically Attended Visit
Time frame: Day 1 thru day 70
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38309519Kimberlin DW, Aban I, Peri K, Nishikawa JK, Bernatoniene J, Emonts M, Klein N, Bamford A, DeBiasi RL, Faust SN, Jones CE, McMaster P, Caserta M, Ahmed A, Sharland M, Demmler-Harrison G, Hackett S, Sanchez PJ, Shackley F, Kelly D, Dennehy PH, Storch GA, Whitley RJ, Griffiths P; Collaborative Antiviral Study Group (CASG). Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial. J Pediatr. 2024 May;268:113934. doi: 10.1016/j.jpeds.2024.113934. Epub 2024 Feb 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valganciclovir in people with Cytomegalovirus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. (time frame: Day 1 through Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01649869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.