Symptomatic Congenital Cytomegalovirus. MedDRA version: 14.1 Level: PT Classification code 10010430 Term: Congenital cytomegalovirus infection System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Valcyte 50 mg/ml Powder for Oral Solution
Product Name: Valganciclovir
Pharmaceutical Form: Oral solution
INN or Proposed INN: VALGANCICLOVI
Sponsors
University College london
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Signed informed consent from parent(S) or legal guardian (s) 2. Confirmation of CMV from urine or throat swab specimend by culture, shell vial, or PCR tests 3. Symptomatic congenital CMV disease, as manifest by one or more of the following: Thrombocytopenia, Petechiae, Hepatomegaly, Splenomegaly, Intrauterine growth restriction, Hepatitis (elevated transaminases and/or bilirubin), Central nervous system involvement of CMV disease (such as microcephaly), radiographic abnormalities indicative of CMV Central Nervous system disease, abnormal Cerebral Spinal Fluid (CSF) indices for age, chorioretinitis, hearing deficits as detected by formal brainstem evoked response (not a screening ABR), and/or a positive CMV PCR from CSF. 4. Less than or equal to 30 days of age at study enrollment 5. Weight at study enrollment greater than or equal to 1800 grams 6. Gestational age greater than or equal to 32 weeks at birth Are the trial subjects under 18? yes Number of subjects for this age range: 104 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Imminent demise 2. Patients recieving other antiviral agents or immune globulin 3. Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g. a history of necrotizing enterocolitis) 4. Documented renal nsufficiency, as noted by a creatinine clearance less than 10 mL/min/1.73m2 at time of study enrollment 5. Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribivir 6. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry) 7. Current receipt of other investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether six months of antiviral treatment with oral valganciclovir improves hearing outcome in infants with symptomatic congenital CMV disease compared to six weeks.; Secondary Objective: To compare the safety profile of six weeks vs six months of antiviral therapy with valganciclovir oral solution in infants with symptomatic congenital CMV. To compare the impact on neurologic outcomes of six weeks versus six months of antiviral treatment with valganciclovir oral solution in infants with symtomatic congenital CMV disease. To correlate change in amount of virus in blood with hearing and neurologic outcomes. To further assess how valganciclovir drug acts in babies and assess how well babies tolerate treatment. ;Primary end point(s): The primary endpoint is the change in best ear hearing assessments between baseline and 6 months, and will be assessed for the analysis population only (those subjects randomized to 6 weeks or 6 months of oral valganciclovir).;Timepoint(s) of evaluation of this end point: baseline, 6 months, 12 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Adverse events which lead to permanent discontinuation of valganciclovir therapy or to irreversible outcome of the adverse event. 2. Change in best ear hearing assessments between baseline and 12 months. 3. Change in best ear hearing assessments between baseline and 24 months. 4. Maximum change in hearing assessments between baseline and 6, 12, and 24 months over left and right ears. 5. Hearing deterioration between baseline and 6, 12, or 24 months over left and right ears. 6. Neurologic impairment at 12 months of life, utilizing the Bayley Scales of Infant and Toddler Development. 7. Neurologic impairment at 24 months of life, utilizing the Bayley Scales of Infant and Toddler Development. ;Timepoint(s) of evaluation of this end point: During the six month treatment period and the one month thereafter, study subjects will be followed weekly for four weeks, then every other week for eight weeks, then every month for four months.Neurodevelopmental assessments at 12 months and 24 months. | — |
Countries
United Kingdom, United States
Contacts
Public ContactProfessor Paul Griffiths
Univesity College London
Outcome results
None listed