Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

July 31, 2022

Study Completion Date

July 31, 2024

Conditions
Cmv CongenitalCMVCongenital CmvSNHLSensorineural Hearing Loss
Interventions
DRUG

Valganciclovir

Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.

DRUG

Simple Syrup

Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.

Trial Locations (30)

10021

Weill Cornell Medicine, New York

10032

Columbia University Medical Center, New York

10469

The Children's Hospital at Montefiore, The Bronx

11040

Cohen Children's Medical Center, New York

11203

SUNY Downstate Medical Center, Brooklyn

15224

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

23507

Children's Hospital of The King's Daughters, Norfolk

29425

Medical University of South Carolina, Charleston

30322

Children's Healthcare of Atlanta, Atlanta

37232

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

43205

Nationwide Children's Hospital, Columbus

46202

Indiana University School of Medicine, Indianapolis

48109

Mott Children's Hospital, Ann Arbor

52242

University of Iowa, Iowa City

55455

University of Minnesota Masonic Children's Hospital, Minneapolis

60611

Lurie Children's Hospital, Chicago

63103

Saint Louis Universtiy, St Louis

64108

Children's Mercy Hospital, Kansas City

75235

UT Southwestern, Dallas

77030

Baylor College of Medicine, Houston

84132

Primary Children's Hospital, Salt Lake City

87131

University of New Mexico, Albuquerque

92123

Rady Children's Hospital - San Diego, San Diego

94158

UCSF Benioff Children's Hospital, San Francisco

94304

Lucile Packard Children's Hospital, Palo Alto

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

02114

Massachusetts Eye and Ear, Boston

03756

Children's Hospital at Dartmouth-Hitchcock, Lebanon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

collaborator

Genentech, Inc.

INDUSTRY

lead

Albert Park

OTHER

NCT03107871 - Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants | Biotech Hunter | Biotech Hunter