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

• Status: Completed
• Trial end date: 2019-12-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); University of Alabama at Birmingham
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

1. Signed informed consent from parent(s) or legal guardian(s)

2. Sensorineural hearing loss (>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)

3. Children from 1 month through 3 years of age (up to the 4th birthday)

Exclusion Criteria:

1. Imminent demise

2. Profound sensorineural hearing loss (> 90dB) in both ears

3. Patients receiving other antiviral agents or immune globulin

4. Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)

5. Documented renal insufficiency, as noted by a creatinine clearance < 10 mL/min/1.73m2 at time of study enrollment

6. Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribavir

7. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).

8. Current receipt of other investigational drugs

9. Previous receipt of ganciclovir or valganciclovir

10. Known hypersensitivity to ganciclovir, valganciclovir, or components of the product

11. Inability to attend follow-up hearing and clinical assessments

12. Infants with Auditory neuropathy/dyssynchrony.

13. Children with another known etiology for SNHL (e.g. connexin 26, syndrome or metabolic disorder associated with SNHL, inner ear malformation and widened vestibular aqueducts, meningitis).

Exclusion of each of these conditions is not required for trial enrollment.