Trial · NCT01649869
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
NCT01649869, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2021-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss. Trials, record NCT01649869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01649869
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
- NCT number
- NCT01649869
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Cytomegalovirus Infection
- Interventions
- Placebo, Valganciclovir
- First posted
- 2012-07-25
- Last updated
- 2024-10-16
- Results first posted
- 2021-06-02
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. | 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. |
| Secondary | 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]. | 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. 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. |
| Secondary | Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6. | 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. |
| Secondary | Change in Best Ear Hearing Assessments [Worse + no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6. | 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. |
| Secondary | Change in Best Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6. | 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. |
| Secondary | Change in Total Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6. | 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. |
| Secondary | Change in Total Ear Hearing Assessments [Worse+ no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6. | 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. |
| Secondary | Change in Total Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6. | 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. |
| Secondary | Association of Change in Viral Load (Blood) With Change in Total Ear Hearing at 6 Months | 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. |
| Secondary | Association of Change in Viral Load (Saliva) With Change in Total Ear Hearing at 6 Months | 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. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. | Day 1 through Day 180 | Ears | NUMBER | |
| SECONDARY | 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]. | Day 1 through Day 180 | Participants | NUMBER | |
| SECONDARY | Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6. | Day 1 through Day 180 | Participants | NUMBER | |
| SECONDARY | Change in Best Ear Hearing Assessments [Worse + no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6. | Day 1 through Day 180 | Participants | NUMBER | |
| SECONDARY | Change in Best Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6. | Day 1 through Day 180 | Participants | NUMBER | |
| SECONDARY | Change in Total Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6. | Day 1 through Day 180 | Ears | NUMBER | |
| SECONDARY | Change in Total Ear Hearing Assessments [Worse+ no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6. | Day 1 through Day 180 | Ears | NUMBER | |
| SECONDARY | Change in Total Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6. | Day 1 through Day 180 | Ears | NUMBER | |
| SECONDARY | Association of Change in Viral Load (Blood) With Change in Total Ear Hearing at 6 Months | At 6 months | Analysis was stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows below | log 10 copies/ml | MEAN |
| SECONDARY | Association of Change in Viral Load (Saliva) With Change in Total Ear Hearing at 6 Months | At 6 months | Analysis stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows belos | log 10 copies/ml | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. | Placebo | Improve + no change | 27 | Ears | |
| Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. | Active | Improve + no change | 20 | Ears | |
| Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. | Placebo | Worsened | 1 | Ears | |
| Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. | Active | Worsened | 6 | Ears | |
| 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]. | Placebo | Improved + normal to normal | 9 | Participants | |
| 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]. | Active | Improved + normal to normal | 6 | Participants | |
| 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]. | Placebo | No change abnormal or worsened | 6 | Participants | |
| 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]. | Active | No change abnormal or worsened | 6 | Participants | |
| Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6. | Placebo | Improved | 0 | Participants | |
| Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6. | Active | Improved | 0 | Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | STARTED | Active | 17 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | Active | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Active | 1 |
Source ClinicalTrials.gov
Adverse events122
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decrease in hemoglobin | Blood and lymphatic system disorders | Placebo | 1 | 18 | 1 |
| other | Decrease in hemoglobin | Blood and lymphatic system disorders | Active | 0 | 17 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 18 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Active | 1 | 17 | 1 |
| other | Monocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 18 | 0 |
| other | Monocytopenia | Blood and lymphatic system disorders | Active | 1 | 17 | 1 |
| other | Bilateral ear infection | Ear and labyrinth disorders | Placebo | 1 | 18 | 1 |
| other | Bilateral ear infection | Ear and labyrinth disorders | Active | 0 | 17 | 0 |
| other | Otitis Media | Ear and labyrinth disorders | Placebo | 1 | 18 | 1 |
| other | Otitis Media | Ear and labyrinth disorders | Active | 1 | 17 | 1 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | Active | 0 | 17 |
| Total, other adverse events | Placebo | 18 | 35 |
| Total, other adverse events | Active | 17 | 35 |
| Total, serious adverse events | Placebo | 0 | 18 |
| Total, serious adverse events | Active | 1 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38309519 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active vs Placebo: deaths from any cause | Trial comparisons |
| Active vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01649869
GET https://conductscience.org/api/trials/v1/NCT01649869/registered?page=2