Trial · NCT00466817
Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
NCT00466817, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2013-11-13
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ConductScience Library. Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections. Trials, record NCT00466817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00466817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
- NCT number
- NCT00466817
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 109 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Cytomegalovirus Infection
- Interventions
- Placebo, Valganciclovir
- First posted
- 2007-04-27
- Last updated
- 2015-08-26
- Results first posted
- 2013-11-13
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Best Ear Hearing Assessments at 6 Months. | Between baseline and 6 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| Secondary | Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | baseline through 7 months | Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event. |
| Secondary | Change in Best Ear Hearing Assessments at 12 Months. | Between baseline and 12 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| Secondary | Change in Best Ear Hearing Assessments at 24 Months. | Between baseline and 24 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| 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) | Between baseline and 6 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| 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) | Between baseline and 12 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| 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) | Between baseline and 24 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| 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) | Between baseline and 6 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| 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) | Between baseline and 12 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
| 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) | Between baseline and 24 months | Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Best Ear Hearing Assessments at 6 Months. | Between baseline and 6 months | 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 | participants | NUMBER |
| SECONDARY | Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | baseline through 7 months | participants | NUMBER | |
| SECONDARY | Change in Best Ear Hearing Assessments at 12 Months. | Between baseline and 12 months | 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 | participants | NUMBER |
| SECONDARY | Change in Best Ear Hearing Assessments at 24 Months. | Between baseline and 24 months | 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 | participants | NUMBER |
| 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) | Between baseline and 6 months | 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 | ears | NUMBER |
| 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) | Between baseline and 12 months | Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed. | ears | NUMBER |
| 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) | Between baseline and 24 months | 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. | ears | NUMBER |
| 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) | Between baseline and 6 months | 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 | ears | NUMBER |
| 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) | Between baseline and 12 months | 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 | ears | NUMBER |
| 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) | Between baseline and 24 months | 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. | ears | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Best Ear Hearing Assessments at 6 Months. | Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo | Worsened | 3 | participants | |
| Change in Best Ear Hearing Assessments at 6 Months. | Valganciclovir: 24 Wks of Valganciclovir | Worsened | 5 | participants | |
| Change in Best Ear Hearing Assessments at 6 Months. | Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo | No Change | 37 | participants | |
| Change in Best Ear Hearing Assessments at 6 Months. | Valganciclovir: 24 Wks of Valganciclovir | No Change | 36 | participants | |
| Change in Best Ear Hearing Assessments at 6 Months. | Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo | One point improvement | 3 | participants | |
| Change in Best Ear Hearing Assessments at 6 Months. | Valganciclovir: 24 Wks of Valganciclovir | One point improvement | 2 | participants | |
| Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo | Permanent discontinuation of study drug | 0 | participants | |
| Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | Valganciclovir: 24 Wks Valganciclovir | Permanent discontinuation of study drug | 0 | participants | |
| Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo | Irreversible outcome from use of study drug | 0 | participants | |
| Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. | Valganciclovir: 24 Wks Valganciclovir | Irreversible outcome from use of study drug | 0 | participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 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: 6 Wks Valganciclovir Followed by 18 Wks of Placebo | 49 | |
| Overall Study | STARTED | Valganciclovir: 24 Wks of Valganciclovir | 47 | |
| Overall Study | COMPLETED | Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo | 44 | |
| Overall Study | COMPLETED | Valganciclovir: 24 Wks of Valganciclovir | 43 | |
| Overall Study | NOT COMPLETED | Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo | 5 | |
| Overall Study | NOT COMPLETED | Valganciclovir: 24 Wks of Valganciclovir | 4 |
Source ClinicalTrials.gov
Adverse events573
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 | Anaemia | Blood and lymphatic system disorders | Non Randomized | 2 | 13 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Active | 5 | 47 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo After 6 Weeks of Valganciclovir | 9 | 49 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Non Randomized | 0 | 13 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Active | 11 | 47 | 15 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo After 6 Weeks of Valganciclovir | 14 | 49 | 33 |
| other | Neutropenia Neonatal | Blood and lymphatic system disorders | Non Randomized | 0 | 13 | 0 |
| other | Neutropenia Neonatal | Blood and lymphatic system disorders | Active | 1 | 47 | 2 |
| other | Neutropenia Neonatal | Blood and lymphatic system disorders | Placebo After 6 Weeks of Valganciclovir | 0 | 49 | 0 |
| other | Red blood cell abnormality | Blood and lymphatic system disorders | Non Randomized | 0 | 13 | 0 |
1 to 10 of 573Source ClinicalTrials.gov
See all 573 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non Randomized | ||
| Total, all-cause mortality | Active | ||
| Total, all-cause mortality | Placebo After 6 Weeks of Valganciclovir | ||
| Total, other adverse events | Non Randomized | 3 | 13 |
| Total, other adverse events | Active | 45 | 47 |
| Total, other adverse events | Placebo After 6 Weeks of Valganciclovir | 47 | 49 |
| Total, serious adverse events | Non Randomized | 1 | 13 |
| Total, serious adverse events | Active | 11 | 47 |
| Total, serious adverse events | Placebo After 6 Weeks of Valganciclovir | 19 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25738669 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT00466817
GET https://conductscience.org/api/trials/v1/NCT00466817/registered?page=2