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NCT01649869 · ClinicalTrials.gov registry record · Phase 2
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT01649869 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 54 participants.
The verdict
NCT01649869, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study 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. 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.
Interventions
- OTHER Placebo
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-02-24 |
| Est. Completion | 2019-12-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01649869
The ClinicalTrials.gov registry entry for NCT01649869 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01649869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01649869 about?
NCT01649869 is a clinical study titled "Valganciclovir Therapy in Infants and Children With Congenital CMV 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 w...
What is the current status of trial NCT01649869?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2015-02-24. Estimated completion is 2019-12-24.
What interventions are being tested in trial NCT01649869?
The interventions under investigation include: Placebo (OTHER), Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT01649869?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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