CompletedPhase 2

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

United States54 participantsStarted 2015-02-24

Plain-language 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.

Who can participate

Age range1 Month – 4 Years

SexALL

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Inclusion criteria

✓. Signed informed consent from parent(s) or legal guardian(s)
✓. Sensorineural hearing loss (\>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)
✓. Children from 1 month through 3 years of age (up to the 4th birthday)

Exclusion criteria

✕. Imminent demise
✕. Profound sensorineural hearing loss (\> 90dB) in both ears
✕. Patients receiving other antiviral agents or immune globulin
✕. Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
✕. Documented renal insufficiency, as noted by a creatinine clearance \< 10 mL/min/1.73m2 at time of study enrollment
✕. Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribavir
✕. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
✕. Current receipt of other investigational drugs

What they're measuring

Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing.

Timeframe: Day 1 through Day 180

Trial details

NCT IDNCT01649869

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-12-24

Results submitted2020-12-23

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