Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

February 24, 2015

Primary Completion Date

December 24, 2019

Study Completion Date

December 24, 2019

Conditions
Cytomegalovirus Infection
Interventions
OTHER

Placebo

Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

DRUG

Valganciclovir

Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Trial Locations (18)

77030

Texas Medical Center - Texas Children's Hospital, Houston

35233-0011

Children's of Alabama Child Health Research Unit (CHRU), Birmingham

20010-2916

Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease, Washington D.C.

63110-1010

Washington University School of Medicine in St. Louis - Center for Clinical Studies, St Louis

11030-3816

Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease, Manhasset

14642-0001

University of Rochester Medical Center, Rochester

28203-5812

Carolinas Medical Center - Pediatrics - Infectious Diseases, Charlotte

43205-2664

Nationwide Children's Hospital - Neonatology - Center for Perinatal Research, Columbus

02903-4923

Rhode Island Hospital - Pediatrics, Providence

BS2 8BJ

Bristol Royal Hospital for Children - Paediatric Immunology, Bristol

SW17 0QT

Saint George's Hospital - Pediatric Infectious Diseases, London

WC1N 3JH

Great Ormond Street Hospital - Infectious Diseases, London

B9 5SS

Birmingham Heartlands Hospital, Birmingham

M8 5RB

Pennine Acute Hospitals NHS Trust, North Manchester General Hospital - Children's and Adolescent Services, Crumpsall

OX3 9DU

John Radcliffe Hospital - Children's Hospital - Paediatric Infectious Disease and Immunology, Headington, Oxford

NE14LP

The Great North Children's Hospital - Paediatric Immunology, Newcastle upon Tyne

S10 2TH

Sheffield Children's Hospital - Immunology, Sheffield

SO16 6YD

Southampton Children's Hospital - Allergy, Immunology and Infection, Southampton, Hampshire

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01649869 - Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss | Biotech Hunter | Biotech Hunter