NCT00466817

A Phase III, Randomized, Placebo-Controlled Blinded Investigation of Six Weeks vs. Six Months of Oral Valganciclovir Therapy in Infants With Symptomatic Congenital Cytomegalovirus Infection (CASG 112)

Completed Phase 3 Results posted Last updated 13 August 2015

What this trial tests

Phase 3 trial testing Placebo in Cytomegalovirus Infection in 109 participants. Completed in 1 June 2013.

Timeline

1 June 2008

Primary endpoint
1 December 2011

1 June 2013

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	109
Start date	1 June 2008
Primary completion	1 December 2011
Estimated completion	1 June 2013
Sites	48 locations across United States, United Kingdom

Drugs / interventions tested

• Placebo
• Valganciclovir (VALGANCICLOVIR) — full drug profile →

Conditions studied

• Cytomegalovirus Infection — all drugs for Cytomegalovirus Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Under 30 Days, any sex, with Cytomegalovirus Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Best Ear Hearing Assessments at 6 Months.
  Time frame: 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

Sponsor's own description

Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment. Participants will include 104 infants (30 days old or younger) born with CMV disease. All infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period, subjects will be assigned by chance to receive either valganciclovir or placebo (inactive substance) to complete the 6 months of antiviral treatment. Patients will be followed for the study related evaluations of safety, changes to hearing, and developmental milestones for up to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus, participants may be involved in study related procedures for approximately 5 years.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The "silent" global burden of congenital cytomegalovirus.
   Manicklal S, Emery VC, Lazzarotto T, Boppana SB, et al · · 2013 · cited 709× · PMID 23297260 · DOI 10.1128/cmr.00062-12
2. Valganciclovir for symptomatic congenital cytomegalovirus disease.
   Kimberlin DW, Jester PM, Sánchez PJ, Ahmed A, et al · · 2015 · cited 518× · PMID 25738669 · DOI 10.1056/nejmoa1404599
3. Hearing Function, Degeneration, and Disease: Spotlight on the Stria Vascularis.
   Thulasiram MR, Ogier JM, Dabdoub A. · · 2022 · cited 39× · PMID 35309932 · DOI 10.3389/fcell.2022.841708
4. Emergence of antiviral resistance during oral valganciclovir treatment of an infant with congenital cytomegalovirus (CMV) infection.
   Choi KY, Sharon B, Balfour HH, Belani K, et al · · 2013 · cited 16× · PMID 23688863 · DOI 10.1016/j.jcv.2013.04.004
5. Severe late-onset multisystem cytomegalovirus infection in a premature neonate previously treated for congenital infection.
   El-Sayed MF, Goldfarb DM, Fulford M, Pernica JM. · · 2013 · cited 4× · PMID 24024982 · DOI 10.1186/1471-2431-13-142