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

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ClinicalTrials.gov Identifier: NCT01649869
Recruitment Status : Recruiting
First Posted : July 25, 2012
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

July 20, 2012
July 25, 2012
June 8, 2018
February 24, 2015
July 27, 2019   (Final data collection date for primary outcome measure)
Change in total ear hearing assessments (improved + no change versus other) [ Time Frame: From Day 1 through Day 180 ]
The proportion of children whose sensorineural hearing deteriorates from baseline [ Time Frame: Baseline to 6 months ]
Complete list of historical versions of study NCT01649869 on ClinicalTrials.gov Archive Site
  • Change in best ear hearing assessments (improved + no change (normal to normal) versus other) [ Time Frame: From Day 1 through Day 180 ]
  • Change in best ear hearing assessments (improved versus other) [ Time Frame: From Day 1 through Day 180 ]
  • Change in best ear hearing assessments (worse + no change (abnormal to abnormal)) versus other [ Time Frame: From Day 1 through Day 180 ]
  • Change in best ear hearing assessments (worse versus other) [ Time Frame: From Day 1 through Day 180 ]
  • Change in total ear hearing assessments (improved versus other) [ Time Frame: From Day 1 through Day 180 ]
  • Change in total ear hearing assessments (worse + no change (abnormal to abnormal)) versus other [ Time Frame: From Day 1 through Day 180 ]
  • Change in total ear hearing assessments (worse versus other) [ Time Frame: From Day 1 through Day 180 ]
  • Correlation of change in viral load with change in best ear hearing [ Time Frame: Day 180 ]
  • Correlation of change in viral load with change in total ear hearing [ Time Frame: Day 180 ]
  • Detection of CMV in saliva by PCR [ Time Frame: Day 180 ]
  • Detection of CMV in saliva by PCR [ Time Frame: Day 42 ]
  • Detection of viremia by PCR [ Time Frame: Day 180 ]
  • Detection of viremia by PCR [ Time Frame: Day 42 ]
  • Detection of viruria by PCR [ Time Frame: Day 180 ]
  • Detection of viruria by PCR [ Time Frame: Day 42 ]
  • Incidence of adverse events which lead to an unresolved outcome [ Time Frame: Up to Day 57 ]
  • Incidence of adverse events which lead to permanent discontinuation of valganciclovir therapy [ Time Frame: Up to Day 42 ]
  • Incidence of unanticipated medically attended visits [ Time Frame: From Day 1 through Day 56 ]
  • The quantitative log reduction in CMV viral load in saliva [ Time Frame: Day 42 ]
  • The quantitative log reduction in viremia [ Time Frame: Day 42 ]
  • The quantitative log reduction in viruria [ Time Frame: Day 42 ]
  • The proportion of children who have viruria detected by PCR [ Time Frame: 6 weeks and six months after trial entry ]
  • The quantitative log reduction in viruria [ Time Frame: Baseline to end of 6 weeks of therapy ]
  • The proportion of children who have viremia [ Time Frame: 6 weeks and six months after trial entry ]
  • The quantitative log reduction in viremia [ Time Frame: Baseline to end of 6 weeks of therapy ]
  • The proportion of children who have CMV detected in saliva by PCR [ Time Frame: 6 weeks and six months after trial entry ]
  • The quantitative log reduction in CMV viral load in saliva [ Time Frame: Baseline to end of 6 weeks of therapy ]
  • The proportion of children whose sensorineural hearing improves or remains unchanged from baseline when measured [ Time Frame: Baseline to 6 months ]
Not Provided
Not Provided
 
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
A Phase II Randomized and Controlled Investigation of Six Weeks of Oral Valganciclovir Therapy in Infants and Children With Congenital Cytomegalovirus Infection and Hearing Loss
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.
Congenital cytomegalovirus (CMV) infection is the most frequent known viral cause of mental retardation, and is the leading non-genetic cause of sensorineural hearing loss in many countries including the United States. This is a Phase II international, multi-center, double-blind, placebo-controlled evaluation of 6 weeks of oral valganciclovir treatment or 6 weeks of placebo for fifty-four male and female infants/toddlers 1 month through 3 years of age (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Patient who are between 1 month and 4 years of age and who have SNHL (Sensorineural Hearing Loss) and are eligible for enrollment. The expected study duration is 3.5 years from enrollment of first study subject. 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. The secondary objective is to define the following responses as a function of systemic exposure to ganciclovir (active metabolite of valganciclovir): CMV viral load in blood; CMV viral load in urine; and CMV viral load in saliva. Also, to define the safety and tolerability of valganciclovir in enrolled subjects. The tertiary objective is to define the pharmacokinetics of ganciclovir (metabolite) following administration of valganciclovir (prodrug) in enrolled subjects.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cytomegalovirus Infection
  • 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.
  • Active Comparator: Active
    27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks
    Intervention: Drug: Valganciclovir
  • Placebo Comparator: Placebo
    27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
Same as current
February 1, 2020
July 27, 2019   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
1 Month to 4 Years   (Child)
No
Contact: David W Kimberlin 12059345316 dkimberlin@peds.uab.edu
United Kingdom,   United States
 
 
NCT01649869
11-0069
HHSN272201100035C
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
March 22, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP